Food Safety Practices Guidance for Moulded Chocolate Manufacturers

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Table of Contents

Preface

According to the National Confectioners Association (NCA), chocolate is the top selling confectionery – over gum, mints, gummies, licorice and other sweets. Chocolate sales in North America topped $16.3 billion in 2007, representing over 3.5 billion pounds of chocolate (NCA 2011). While chocolate continues to grow in popularity, the emergence of a number of food recalls associated with Salmonella spp. contamination and undeclared allergens, as well as a recent outbreak of food-related illness linked to chocolate products, suggest that manufacturers may need to consider new approaches to improve the safety of chocolate.

The potential for raw cocoa beans to be contaminated with Salmonella spp. is well established. Canada's Food and Drug Regulations specifically address this hazard with Section B.04.012 which prohibits the sale of cocoa or chocolate products containing Salmonella. Unless roasting of the cocoa bean is adequate and handling of roasted beans is well controlled, the intermediate chocolate products such as cocoa powder, cocoa butter or cocoa liquor may be contaminated with Salmonella spp. (ICMSF 1986). The low water activity of these intermediate products is known to increase Salmonella's resistance to heat, such that small numbers of Salmonella spp. have been shown to survive typical temperatures reached during the milling, refining, or conching steps of chocolate processing (Lund et al. 2000). Salmonella spp. can also be introduced to chocolate products by other contaminated ingredients, by contaminated processing equipment or by inappropriate employee handling practices.

For individuals with food allergies, consuming a pre-packaged food containing an undeclared allergen can be life-threatening. Priority food allergens of concern in Canada include: peanuts, tree nuts, milk, soy, wheat, sulphites, sesame seeds, eggs and seafood (fish, crustaceans and shellfish). Undeclared allergens can be present in a pre-packaged food as a result of cross-contamination or carry-over, inadequate allergen control on incoming ingredients, inappropriate use of rework, the application of an incorrect label or an incorrect list of ingredients on a label.

Risk can be significantly reduced through strict adherence to Good Manufacturing Practices, especially where the principles of Hazard Analysis Critical Control Points (HACCP) are applied to the process.

In an effort to help reduce the risk posed by Salmonella spp. and undeclared food allergens in moulded chocolate and to assist manufacturers that wish to adopt a Hazard Analysis Critical Control Point (HACCP) approach, CFIA has developed the Food Safety Practices Guidance for Moulded Chocolate Manufacturers document. The guide uses the General Principles of Food Hygiene and Consumer Packaging and Labelling (GPFHCL) as its core and has incorporated additional reference material to create a suggested prerequisite program. Developed by the CFIA with input from a number of interested parties, including the Canadian chocolate industry, Health Canada and provincial government representatives, this document provides guidance on potential hazards and controls related to a HACCP approach. As well, this guidance document is designed to address other factors that affect product integrity, including composition, compliance with standards, and labelling requirements. This guidance document is being offered to manufacturers as a food safety resource.

HACCP is a systematic approach that assesses each step in a food manufacturing process for potential hazards. HACCP is recognized by regulators, industry and academia as a reliable food safety approach available to the food industry. Prior to the application of a HACCP system, an establishment should be operating in accordance with Good Manufacturing Practices (GMPs), applicable food safety legislation and should have the guidance of a person trained in HACCP. The GMPs (prerequisite programs) serve as the building blocks upon which a HACCP plan is built.

A HACCP system is developed following a careful review and analysis of the unique processing facility in which it is to be implemented. Chapter 1 of this guidance document primarily provides guidance related to hazard analysis and control of the manufacturing process, while chapters 2 to 8 provide guidance related to a generic prerequisite program. The intent of this guidance document is that processors wishing to develop their own HACCP program can modify or adapt this generic guide to suit their particular facility and operation.

It is hoped that this document will complement existing references and the initiatives of other agencies, to make it easier for chocolate manufacturers to adopt a HACCP approach and ultimately produce the safest possible product.

Scope

As per Section B.04.001 of the Food and Drug Regulations (FDR), chocolate product means a product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate.

The scope of this guidance document includes moulded chocolate products containing a significant amount of standardized chocolate with or without minor amounts of additional ingredients such as nuts, peanuts and raisins. Examples of products included in the scope of this document include solid moulded chocolate bars and chocolate bars with nuts and raisins. Products outside the scope of this document include compound chocolate and chocolate coated products or chocolate cookies.

Packaging includes consumer and institutional packages in varying formats and materials (e.g., foil, plastic, paper and cardboard).

Hazard Summary for Moulded Dark Chocolate With Almonds

In developing the following table, the manufacture of moulded dark chocolate with almonds was used as an example to illustrate potential hazards and possible control measures associated with the manufacture of moulded chocolate products. This table may not cover all possible ingredients, process steps or all potential hazards associated with moulded chocolate production. The manufacturer is responsible for identifying hazards specific to their operation and for determining how each hazard could be controlled. For additional information, refer to specific sections of this document as provided in the Reference column.

Process StepPotential HazardsControl MeasuresReference
Incoming Materials/ Receiving Presence of pathogenic microorganisms (e.g. Salmonella spp.) in chocolate blocks and/or other ingredients at risk (e.g. raw almonds).

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds, and packaging materials provided meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Obtain a Certificates of Analysis for each lot of chocolate or other ingredients at risk (e.g. raw almonds) to confirm that they do not contain Salmonella spp. and pose no other microbial hazard.

Check incoming materials against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming ingredients and materials at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming materials to verify the accuracy of the Certificate of Analysis and/or that the incoming materials meet the purchase specifications as indicated in the Letter(s) of Guarantee.

1.4, 1.11
Incoming Materials/ Receiving Presence of undeclared allergens (e.g. milk, tree nuts, peanuts) in incoming ingredients and/or packaging materials.

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds, and packaging materials provided meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients and materials against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming ingredients and materials at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming materials to verify the accuracy of the Certificate of Analysis and/or that the incoming materials meet the purchase specifications as indicated in the Letter(s) of Guarantee.

1.4, 1.11
Incoming Materials/ Receiving Presence of hazardous extraneous material in incoming ingredients and/or packaging materials (e.g. glass, stones, metal).

Obtain a guarantee from the supplier(s) that the chocolate blocks, roasted almonds and packaging materials meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming materials and materials against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming ingredients and materials at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming ingredients and materials that do not meet specifications.

1.4
Incoming Materials/ Receiving Presence of potentially hazardous chemicals in excess of safe levels (e.g. pesticides, heavy metals, food additives) in ingredients.

Obtain a guarantee from the supplier(s) that the chocolate blocks and roasted almonds meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming ingredients at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming ingredients that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming ingredients to verify the accuracy of the Certificate of Analysis and/or that the incoming materials meet the purchase specifications as indicated in the Letter(s) of Guarantee.

1.4, 1.11
Materials/ Receiving (packaging material) Presence of potentially hazardous chemicals associated with non-food grade packaging materials.

Obtain a guarantee from the supplier(s) that the packaging materials meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming materials against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming materials at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming materials that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming materials to verify the accuracy of the Certificate of Analysis and/or that the incoming materials meet the purchase specifications as indicated in the Letter(s) of Guarantee.

1.4, 1.11
Incoming Materials/ Receiving (dark chocolate blocks, roasted almonds, returned product) Presence of mycotoxins (e.g. aflatoxin, ochratoxin A) in ingredients (e.g. almonds).

Obtain a guarantee from the supplier(s) that the chocolate blocks and roasted almonds meet the establishment's purchase specifications (e.g. the supplier provides a Letter of Guarantee).

Check incoming ingredients against predetermined screening criteria when received (e.g. company purchase specifications).

Inspect all incoming ingredients at receiving to confirm that purchase specifications are met.

Do not accept and/or use incoming ingredients that do not meet specifications.

At a scheduled frequency, analyze representative samples of incoming ingredients to verify the accuracy of the Certificate of Analysis and/or that the incoming ingredients meet the purchase specifications as indicated in the Letter(s) of Guarantee.

1.4, 1.11
Storage of Incoming Materials
/Rework
Growth of pathogenic microorganisms and/or mycotoxin (e.g. aflatoxin, ochratoxin A) producing mould in almonds due to inappropriate temperature and humidity control during storage. Control temperature/humidity and storage practices to minimize growth of microorganisms and moulds. 1.5, 6.2
Storage of Incoming Materials
/Rework
Contamination of ingredients with allergens due to inadequate separation from allergens or products containing allergens in storage.

Clearly identify allergens and/or products that contain allergens in storage.

Store allergens and products containing allergens separately from other ingredients and/or products that do not contain allergens.

6.2
Storage of Incoming Materials
/Rework
Contamination of ingredients with non-food chemicals (e.g. cleaning product) due to improper storage procedures. Store non-food chemicals in a separate location from all food ingredients and packaging materials. 6.2
Cutting/
Breaking Chocolate Blocks
Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Monitor equipment and utensils regularly to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Melting Tank Presence of undeclared allergens in finished products due to the incorrect addition of dark chocolate containing allergens. Regularly monitor the addition of ingredients to ensure that the correct ingredients are added as indicated in the recipe and/or formulation. 1.6, 1.8
Melting Tank Presence of undeclared allergens in finished product due to the incorrect addition of rework and/or returned product containing allergens. Regularly monitor the addition of rework and/or returned product to ensure that like product is added to like product. 1.6, 1.8, 6.2
Melting Tank Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Regularly monitor equipment and utensils to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Screening/
Magnet
Contamination of the chocolate with hazardous extraneous material (metallic and/or non-metallic) due to accumulation of hazardous extraneous material and/or damage as a result of inadequate inspection and/or cleaning of the screens.

Regularly monitor equipment (e.g. screens) to ensure that it is in good operating condition (e.g. no holes) as part of an effective preventive maintenance program.

Regularly clean screens to ensure that they are in good operation condition (e.g. no accumulation of hazardous extraneous material) as part of an effective sanitation program.

1.8, 2.1
Screening/
Magnet
Contamination of chocolate with metal fragments due to failure of the magnet to remove metal. Regularly monitor equipment (e.g. magnets) to ensure that it is in good operating condition (e.g. functioning normally) as part of an effective preventive maintenance program. 1.8, 2.1
Screening/
Magnet
Contamination of chocolate with hazardous extraneous material (i.e. metal accumulated on magnet is released into final product) due to inadequate inspection and/or cleaning of magnet to remove accumulated metal. Regularly clean magnet to ensure that it is in good operating condition (e.g. no accumulation of metal) as part of an effective preventive maintenance program. 1.8, 2.1
Mixing/
Blending
Presence of undeclared allergens in finished products due to the incorrect addition of allergens that do not appear on the recipe/formulation. Regularly monitor the addition of ingredients to ensure that the correct ingredients are added as indicated in the recipe and/or formulation. 1.6, 1.8, 2.1
Mixing/
Blending
Contamination of chocolate by metal fragments due to equipment and utensil wear and tear. Regularly monitor equipment and utensils (e.g. mixers and blenders) to ensure that they are in good operating condition (e.g. not showing signs of wear, no cracks) as part of an effective preventive maintenance program. 1.8, 2.1
Depositing/ Moulding/ Demoulding Contamination of chocolate with metallic and/or non-metallic (e.g. plastic) hazardous extraneous material from broken/cracked chocolate moulds.

Regularly monitor moulds to ensure that they are in good condition (e.g. not cracked or broken) as part of an effective preventive maintenance program.

Use chocolate moulds that are resistant to cracking or breaking.

1.8, 2.1
Air Cooling Contamination of chocolate with pathogenic microorganisms due to contact with inappropriately sourced and/or contaminated air used for cooling.

Use an appropriate and acceptable source of air and, where necessary, ensure air is filtered.

Regularly monitor air filter to ensure that it is in good condition as part of an effective preventive maintenance program.

1.8, 3.2, 2.1
Air Cooling Presence of non-food chemicals (e.g. refrigerant) on chocolate due to a refrigerant leak during cooling. Regularly monitor cooling units to ensure that they are in good condition (e.g. not leaking refrigerant) as part of an effective preventive maintenance program. 1.8, 2.1
Packaging/
Labelling/
Coding
Presence of undeclared allergens in finished product due to incorrect label application and/or incorrect list of ingredients on the label (e.g. failure to identify almonds as an ingredient on the label) and/or illegible label. Regularly monitor label on product to ensure that the correct label is applied to product and that the label is accurate (includes correct list of ingredients) and legible. 1.2, 1.9
Packaging/
Labelling/
Coding
Incorrect/illegible or missing code on finished product label resulting in an inability to recall product. Regularly monitor product code to ensure that the correct code is applied to product and that the code is accurate and legible. 1.7
Metal Detection Contamination of finished product with metal fragments due to improper calibration of the metal detector. Regularly calibrate the metal detector to ensure that it is functioning as intended. 1.8, 2.1
Metal Detection Contamination of finished product with metal fragments due to ineffective detection by the metal detector and/or failure of the metal detector to function appropriately when metal is detected. Regularly monitor and control the function of the metal detector. 1.8, 2.1
Finished Product Storage Cross-contamination of finished product (e.g. unpackaged product) with allergens due to inadequate separation from product containing allergens in storage.

Clearly identify products that contain allergens in storage.

Store products containing allergens separately from other products that do not contain allergens.

6.2
Finished Product Storage Contamination of finished product with non-food chemicals (e.g. cleaning product) due to improper storage procedures. Store chemicals in a separate location from all food and packaging materials 6.2
Finished Product Storage Contamination of finished product with pathogenic microorganisms and/or allergens due to failure to identify and/or isolate returned, defective or suspect product. Control (e.g. clearly identify and isolate in a designated area) returned, defective or suspect products until appropriate safe disposition. 6.2
Shipping/
Distribution
Contamination of finished product with pathogenic microorganisms, hazardous extraneous material and/or chemicals due to unsanitary carriers and/or damaged packaging. Regularly monitor carriers while loading to ensure that transportation conditions meet the requirements of the establishment for the product being shipped. 6.1
All Process Steps Contamination of chocolate with pathogenic microorganisms, chemicals, allergens and/or hazardous extraneous material due to employee error as a result of a lack of training and/or failure to understand the importance of following written standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs).

Provide employees with training in standard operating procedures (SOPs) and/or Good Manufacturing Practices (GMPs) appropriate to their position and the work being done.

Regularly monitor employee practices while work is being done.

5.2
All Process Steps Contamination of chocolate with pathogenic microorganisms, chemicals, allergens and/or hazardous extraneous material due to improper employee handling practices.

Regularly provide employee training in proper hygiene and correct handling procedures.

Monitor employee practices regularly.

5.1, 5.2
All Process Steps Contamination of chocolate with pathogenic microorganisms and/or chemicals (e.g. cleaning products) due to improper cleaning and/or sanitizing of equipment and facilities. Regularly monitor sanitation procedures and verify the effectiveness of the sanitation program. 4.1
All Process Steps Cross-contamination of finished product with undeclared allergens (e.g. milk ingredients, tree nuts, peanuts) due to failure to use dedicated equipment, moulds and utensils. Regularly monitor to ensure that, where applicable, products containing allergenic ingredients are manufactured in dedicated equipment using dedicated moulds and utensils. 3.2
All Process Steps Cross-contamination of finished product with undeclared allergens as a result of improper cleaning of equipment, moulds and utensils between products containing allergens and products not containing the same allergens. Regularly monitor the sanitation activities and ensure the effectiveness of the procedures and program. 4.1
All Process Steps Cross-contamination of chocolate with allergens from one production line to an adjoining line due to inadequate separation as a result of poor plant design. Ensure plant layout (design) provides adequate separation from one production line to another in order to prevent cross-contamination of allergenic ingredients. 2.1, 3.2
All Process Steps Cross-contamination of chocolate with allergens due to cross-utilization of moulds, utensils and/or equipment between products and/or between product lines. Regularly monitor the use of moulds, utensils and equipment to ensure that there is no cross-utilization between products and/or between product lines to prevent cross-contamination with allergens. 3.2
All Process Steps Cross-contamination of chocolate from pathogenic microorganisms, hazardous extraneous material, and/or chemicals (including lubricants) due to improper equipment design, improper equipment installation and/or improper equipment maintenance (including inadequate cleanup after maintenance).

Use only equipment that has been properly designed and installed to ensure that it will not contaminate food.

Regularly monitor equipment maintenance (including clean-up after maintenance) to ensure that maintenance activities are effective and procedures and programs are effective.

2.1
All Process Steps Contamination of chocolate from pathogenic microorganisms, chemicals and/or hazardous extraneous material due to contamination from overhead structures (e.g. leaking pipes, flaking paint). Regularly monitor overheads to ensure that they are in good condition (e.g. no leaking pipes or flaking paint) as part of an effective preventive maintenance program. 3.2
All Process Steps Contamination of chocolate with pathogenic microorganisms due to contaminated air. Regularly monitor air intake systems and filters to ensure that they are in good operating condition as part of an effective preventive maintenance program. 2.1, 3.2
All Process Steps Contamination of chocolate with pathogenic microorganisms due to the presence of rodents, birds or insects. Regularly monitor the effectiveness of the pest control program. 4.2

Using the Guidance Document

Principle Statement

Principle statements are outcome-based generic statements of objectives similar to those found in the Recommended International Code of Practice – General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex). They are intended to capture the intent of the guideline while allowing flexibility in addressing specific products or processes.

Rationale

Rationales are included only when required to explain the principle statement. They are included in several chapters of this guidance document (Control of Operation, Equipment, Records and Complaint Handling and Recalls) to explain the nature of the concern or potential hazard(s) and the need for control.

Anticipated Outcomes

Anticipated Outcomes are intended to guide the industry by describing the factors influencing the objective underpinning the principle statement. The CFIA recognizes that there may be alternate means of meeting the intent of the principle statement other than those described in this guidance document. For example, these alternative means may include a specific process step that will be used to control an associated food safety risk or meet a regulatory requirement.

Chapter 1 : Control of Operation

1.1 Product Formulation and Composition

1.1.1 Availability and Accuracy of Product Formulae

Current written formulae are available for each product processed.

Rationale

By providing a basis for the assessment of food additives, composition, labelling, nutritional requirements and food allergens, current written formulae provide information aimed at ensuring the production of a consistent product.

Anticipated Outcomes
  • Current written formulae are available for each product.
  • A current technical data sheet is available for each raw material.
  • The formulae contain all details of the formulation as follows:
    • identification of all ingredients (e.g. brand/supplier, concentration, type, common name, specific name of food colours) and components (ingredients of ingredients, such as corn starch and vegetable oil on raisins);
    • amounts of all ingredients, including food additives.
  • Products are formulated to comply with food standards where they exist (see Division 4, of the FDR for chocolate standards).
  • Products are formulated to ensure accurate nutrition declarations (see Section 1.1.3 Compositional Requirements for further details).
  • Written formulae clearly identify allergens present in the formulation.
  • Written formulae are updated to reflect ingredient changes or substitutions to ensure allergens are declared on finished product labels.

1.1.2 Identification of Factors Significant to Food Safety in Product Formulation

Any factors in the product formulation that are significant to a safe process are identified.

Rationale

Inadequate identification of either significant ingredients and their specifications, or key preparation/process steps, may indicate a lack of awareness or a lack of control of significant factors. This could result in an inadequate process, which could affect product safety.

Anticipated Outcomes
  • Ingredients significant to the safety of the process are identified with their specifications.
  • Formulation factors that are key to the safety and integrity of the product are identified. This includes preparation/process steps and microbiological, chemical (e.g. allergens) or physical (e.g. hazardous extraneous material) concerns. Their specifications and limits are identified (e.g. water activity as well as freedom from Salmonella spp.).
  • Manufacturers producing specialty allergen-free products (e.g. peanut-free) ensure the allergen of concern (e.g. peanut) is not present in the ingredients being used.

1.1.3 Compositional Requirements

The nutrient content of the food is controlled to meet declared label values and applicable requirements found in the Food and Drugs Act and Regulations.
Foods for which nutrient content claims and health claims are made meet the compositional requirements of the Food and Drug Regulations.
Products comply with food standards where they exist (Division 4, of the FDR for chocolate standards).

Rationale

Inaccurate nutrition information, nutrient content claims and health claims may pose a health risk for people making food choices based on the nutrient content of the food. Inadequate control of food composition could also result in product misrepresentation. Consumers expect that the declared composition, compositional standards, nutrition information and claims accurately reflect the food's composition.

Anticipated Outcomes
  • The manufacturer has control over the formulation to ensure that all nutrient content declarations and regulatory requirements are met.
  • Product formulations are designed to ensure that standardized food products meet the regulated standards of identity and composition.
  • The manufacturer verifies, as often as necessary, that the Nutrition Facts table is accurate and within tolerance.

Note: The following CFIA documents provide further guidance on composition and labelling issues:

  1. The Evaluation Standard for Nutrition Labelling addresses, in detail, the requirements of the Nutrition Facts table and the factors involved in determining nutrient content and producing a product with a consistent nutrient profile. This document may be found within the Nutrition Labelling Toolkit.
  2. The Guide to Food Labelling and Advertising (GFLA) provides detailed guidance on the requirements for nutrient content and diet-related health claims.
  3. The Nutritional Labelling Compliance Test constitutes the CFIA methodology for assessing the accuracy of nutrition labelling and claims (see 6.11 of the Guide to Food Labelling and Advertising).

1.1.4 Food Additives

Food additives are controlled to meet the requirements of the Food and Drugs Act and Regulations.

Rationale

Inadequate control of food additives and/or processing aids could result in chemical or biological hazards.

Anticipated Outcomes
  • The manufacturer ensures that all food additives used (e.g. food colouring agents) are permitted for use in the particular food and meet the requirements of the Food and Drug Regulations (Division 16 for food additives) and other applicable regulations (see Division 4 of the FDR for standards of chocolate).
  • The manufacturer has chemical specifications (e.g. composition and concentration) for all food additives and/or processing aids and ensures that all specifications are met.
  • Where there are no specifications in the Food and Drugs Act and Regulations, the manufacturer requires that all food additives and/or processing aids meet Food Chemical Codex (FCC) grade specifications or equivalent (e.g. specification sheets, clear identification of the grade on the additive package or blanket guarantees).
  • The manufacturer ensures that processing aids, where permitted, are used at levels in accordance with Good Manufacturing Practices (as per label instructions) and can demonstrate through calculations that food additives are used within the maximum level specified in the Food and Drug Regulations.

Note: A food processing aid is a substance that is used for a technical effect in food processing or manufacture, the use of which does not affect the intrinsic characteristics of the food and results in no or negligible residues of the substance or its by-products in or on the finished food. Upon request, the Food Directorate's Bureau of Chemical Safety of Health Canada will conduct a pre-market assessment and offer advisory comments on the status of a substance as a food additive or a processing aid, and its acceptability for use in food manufacturing or processing.

For additional information, see Health Canada's Policy for Differentiating Food Additives and Processing Aids.

Also see the Guide to Food Labelling and Advertising, Chapter 2, Section 2.8.3, for further information relating to processing aids.

1.2 Labelling and Net Quantity

1.2.1 Labelling / 1.2.2 Net Quantity

The manufacturer has controls in place to ensure that the labels are complete and accurate, and meet the requirements of the Food and Drugs Act and Regulations, the Consumer Packaging and Labelling Act and Regulations and the Weights and Measures Act and Regulations, where applicable.

Rationale

Mandatory information on food labels allows consumers to make informed choices by providing:

  • basic product information (e.g. common name, list of ingredients, net quantity and name and address of the manufacturer);
  • Nutrition Facts table.

Inaccurate labels may also be considered false and misleading and in violation of Section 5.1 of the Food and Drugs Act.

Note: Mandatory information is determined, in part, by the regulatory requirements specific to the commodity in question.

Refer to Chapter 2 (Basic Labelling Requirements) and Chapters 5 to 8 (Nutrition Labelling and Claims) of the Guide to Food Labelling and Advertising for further details.

Labelling of Food Allergens

Inadequate allergen labelling could mislead consumers and could pose a potential health hazard to segments of the population with allergies.

Precautionary labelling may be used to alert consumers with food allergies to the potential presence of a food allergen in a food. Where priority food allergens may inadvertently be present in a food despite Good Manufacturing Practices (GMPs), a precautionary statement may be used following the ingredient list. Precautionary statements are not to be used when an allergen or allergen-containing ingredient is deliberately added to a food. They should be truthful, clear and non-ambiguous and should not be used in lieu of Good Manufacturing Practices.

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens, guidance on the Labelling of Foods Causing Allergens and Sensitivities, a Tool for Managing Allergen Risk in Food Products, and Food Allergies and Allergen Labelling.

For additional information, see Health Canada's policy on The Use of Food Allergen Precautionary Statements on Pre-packaged Foods.

Anticipated Outcomes
  • The manufacturer has procedures in place to ensure that all mandatory information is properly declared on food labels in accordance with Canadian food labelling legislation, and that all label claims are accurate and not misleading, such as "X free" allergen claims.
  • Foods that contain or may contain ingredients that are on Canada's list of priority food allergens are labelled so that consumers are aware of their possible presence.
  • Labels are reviewed both for compliance with Canadian legislation (e.g. presence of mandatory labelling), and for accuracy and correctness of information (e.g. presence of allergens).
  • Where suppliers have labelled raw materials with a precautionary statement, such as "may contain milk", and the allergen is not present in the list of ingredients of the finished product, the manufacturer also uses an appropriate precautionary statement on the finished product label.
  • Where oils, starches or other allergen derived foods, such as lecithin or hydrolyzed protein, may contain any protein from the original allergen source, the manufacturer declares the food allergen source (e.g. soy oil, soy lecithin, egg lecithin or wheat starch).
  • New labels, and changes to current labels (e.g. changes to artwork, text and layout) are reviewed for compliance with Canadian legislation.
  • Incoming labels from labelling and/or printing companies are reviewed against signed-off proofs.
  • Corrective labels applied to products to bring them into compliance are reviewed against signed-off proofs.
  • Changes in packaging or formulations, including ingredients and/or their components, are assessed for their possible impact on product labelling.
  • The manufacturer has controls in place to ensure that the product's net quantity, as stated on the label, is in compliance with Section 39 of the Consumer Packaging and Labelling Regulations (CPLR) and Section 52 of the Weights and Measures Regulations (WMR).

1.3 Process Design

1.3.1 Process Design

The manufacturer demonstrates that foods do not develop any safety hazards (biological, physical or chemical) as a result of process design.

Rationale

Written scientific evidence is necessary to demonstrate that each process adequately ensures the safety of the product. An inadequate process could result in unintentional incorporation of ingredients (e.g. undeclared allergens) or in the lack of control of pathogenic microorganisms, toxins and other hazards.

Anticipated Outcomes
  • For every product, a written description of the process, including procedures, is available. Document control policies are in-place to ensure that copies of operational procedures and supporting information, available to personnel, are always current (e.g. signed and dated).
  • The process is established using accepted scientific methods to minimize the risk associated with biological, chemical and physical hazards. Details of actual experimental methods are available.
  • Where dedicated processing lines are not used to control food allergen contamination, the manufacturer has established and validated procedures for product changeovers that do not result in undeclared allergens.
  • Food safety systems such as HACCP should be used to identify and control food hazards. All Critical Control Points (CCPs) for each product, including the critical limits for each CCP, are identified, tested, evaluated and validated in the development of the process. See the following Process Flow Diagram for a generic process flow and potential CCPs. For further information regarding CCPs rationale see the CFIA's HACCP Generic Model for Moulded Dark Chocolate with Almonds.

See Section 7.2.1 for expected Process Design Records.

A Hazard Analysis and Critical Control Point (HACCP) system is a prevention-based food safety system designed to prevent, reduce to acceptable levels, or eliminate the biological, chemical, and physical hazards associated with food production. One strength of HACCP is its proactive approach to food safety that consists of preventing food contamination rather than trying to identify and control contamination after it has occurred. Chocolate manufacturers may control food hazards through a system based on Hazard Analysis and Critical Control Point (HACCP) principles. They may:

  • identify hazards potentially associated with chocolate and chocolate processing;
  • identify any steps in their operations that are critical for controlling the safety of chocolate;
  • implement effective control procedures at those steps by establishing critical limits;
  • monitor control procedures to ensure their continuing effectiveness;
  • have procedures in place for dealing with deviations from critical limits;
  • verify control procedures periodically and whenever the operations change; and
  • maintain records as specified in Chapter 7 of this guidance document.

A HACCP type program will reduce the risk of unsafe food by taking preventive measures to assure the safety and suitability of food at an appropriate stage in the operation by controlling food hazards.

The HACCP team at each establishment is responsible for the validation of the HACCP system, that is, first validating the hazards that exist in the facility and then validating that the standards for the prerequisite programs (GMPs) and the standards for the critical limits of the Critical Control Point(s) are able to control the hazards. A validation is also to be conducted whenever new procedures, policies or control measures are introduced. If scientific studies and/or government regulations exist in relation to the standard or critical limit, the facility may quote this information as the validation. If not, the facility should conduct a validation study to validate the control measure through testing. Once the initial validation is completed during development of the HACCP system, the facility should conduct a validation of control measures at least once yearly. This yearly validation reviews all of the standards of the prerequisite programs (GMPs), as well as the critical limits of the control points, to ensure that these control measures continue to be effective in controlling the identified hazards.

For additional information on how to build a HACCP system, see Appendix A (Hazard Analysis And Critical Control Point (HACCP) Summary) of this guidance document, the HACCP Generic Model for Moulded Dark Chocolate with Almonds and the CFIA's Food Safety Enhancement Program (FSEP) Manual.

Flow Diagram - Generic Process identifying suggested Critical Control Points (CCPs) for Moulded Chocolate.

See the HACCP Generic Model for Moulded Dark Chocolate with Almonds for more details.

Flow Diagram - Generic Process identifying suggested Critical Control Points (CCPs) for Moulded Chocolate

Description for Generic Process Flow Diagram For Moulded Chocolate

This diagram is a flow chart showing the process for producing moulded chocolate.

The diagram lists the necessary steps from 1 - 19 to be taken in the moulded chocolate production process.

Identified in pink ovals are the Critical Control Points (CCPs). These are next to boxes 6, Melting tank; 12, Mixing/blending; 16, Metal detection; and 17, Packaging/labelling/coding.

Identified in an orange oval is rework. This receives input from steps 13, Depositing/moulding; 14, Air cooling; and 15, Demoulding; and leads to steps 2, Chocolate storage; and 6, Melting tank.

Identified in a green oval is returned product which leads to step 1, Receiving.

Potential for Biological (B), Chemical (C) and/or Physical (P) hazards is indicated in parentheses next to each process step.

  1. Receiving (BCP). Leading to steps 2, Chocolate storage; 3, Almond storage; and 4, Packaging material storage. Receives input from returns.
  2. Chocolate storage (BCP). Leading to steps 5, Cutting/breaking chocolate blocks; and 6, Melting tank. Receives input from rework.
  3. Almond storage (BCP). Leading to step 12, Mixing/blending.
  4. Packaging material storage (BCP). Leading to steps 13, Depositing/moulding; and 17, Packaging/labelling/coding.
  5. Cutting/breaking chocolate blocks (BCP). Leading to step 6, Melting tank.
  6. Melting tank (BCP). CCP-1C. Leading to steps 7, Screening/magnet; and 8, Holding tank. Receives input from rework.
  7. Screening/magnet (BCP). Leading to step 8, Holding tank.
  8. Holding tank (BCP). Leading to step 9, Screening/magnet. Melted chocolate with rework leads to step 12, Mixing/blending.
  9. Screening/magnet (BCP). Leading to step 10, Tempering.
  10. Tempering (BCP). Leading to step 11, Screening/magnet.
  11. Screening/magnet (BCP). Leading to step 12, Mixing/blending.
  12. Mixing/blending (BCP). CCP-2C. Leading to and receives input from step 13, Depositing/moulding.
  13. Depositing/moulding (BCP). Leading to step 14, Air cooling; and rework.
  14. Air cooling (BCP). Leading to step 15, Demoulding; and rework.
  15. Demoulding (BCP). Leading to step 16, Metal detection; and rework. Product packaged prior to metal detection leads to step 17, Packaging/labelling/coding.
  16. Metal detection (BCP). CCP-3P. Leading to step 17, Packaging/labelling/coding. Product packaged prior to metal detection from step 17 is received. This product then proceeds to step 18, Storage; after metal detection.
  17. Packaging/labelling/coding (BCP). CCP-4C. Leading to step 18, Storage. Product packaged prior to metal detection leads to step 16, Metal detection.
  18. Storage (BCP). Leading to step 19, Shipping/distribution.
  19. Shipping/distribution (BCP).

1.4 Incoming Material Control

Note: Where this document is adapted as a Prerequisite Program as part of a HACCP Plan, Section 1.4 Incoming Materials Control (Receiving) and all of its anticipated outcomes may be incorporated into Chapter 6 – Transportation and Storage, following the Food Safety Enhancement Program (FSEP) approach. Chapter 6 in turn may be renamed Transportation, Receiving and Storage.

1.4.1 Incoming Chocolate and Other Non-Packaging Inputs

The manufacturer controls incoming chocolate and other non-packaging inputs so that foods are not exposed to safety hazards (biological, physical and chemical), and they remain both safe and correctly labelled.

Rationale

Prevention of health hazards begins with control of incoming chocolate and other non-packaging inputs. Inadequate incoming product controls, such as a lack of appropriate product testing or a failure to verify labels, could result in the sale of contaminated product or misrepresented product. Specifications provide standards against which the manufacturer can assess the acceptability of the components necessary for the production of the finished product.

Note: The degree of control exercised is appropriate to the level of risk posed by the ingredient to the safety of the food.

Anticipated Outcomes
  • The manufacturer has written microbiological specifications for chocolate and obtains certificates of analysis for each lot of chocolate to confirm that it does not contain Salmonella spp. and poses no other biological hazard.
    Note: for all ingredients, including chocolate, certificates of analysis may also include: enterobacteriaceae or coliforms, E. coli, moulds, yeasts, and Aerobic Colony Count [ACC] including aerobic sporeformers.
  • The manufacturer has written specifications and obtains a Letter of Guarantee from suppliers of chocolate (e.g. CFIA's Allergen Checklist for Food Suppliers and Manufacturers) for information relating to the control of chemical hazards, (e.g. undeclared allergens such as milk ingredients, tree nuts, peanuts, mycotoxins [such as Aflatoxin and Ochratoxin A] and food additives exceeding permitted levels).
  • The manufacturer has written specifications and obtains a Letter of Guarantee from suppliers of chocolate for information relating to the control of physical hazards such as metal.
  • The manufacturer has written specifications for all other ingredients. Supporting information, such as certificates of analysis or Letters of Guarantee, is obtained to confirm that these specifications are met. For example:
    • raw or roasted tree nuts – Salmonella spp., undeclared peanuts or other allergens, mycotoxins such as Aflatoxin (Nut and nut products that contain more than fifteen parts per billion of aflatoxin are considered adulterated and in violation of Section B.01.046 of the Food and Drug Regulations.) and extraneous material such as shells or stones.
    • raw or roasted peanuts – Salmonella spp., undeclared allergens such as tree nuts, mycotoxins such as Aflatoxin (Nut and nut products that contain more than fifteen parts per billion of aflatoxin are considered adulterated and in violation of Section B.01.046 of the Food and Drug Regulations) and extraneous material such as metal or stones.
    • raisins – pesticide residues, heavy metals, sulfites, stones, wood, insects, etc.
    • flavour – non-permitted colours and undeclared allergens.
  • Each lot of incoming material is examined for damaged containers and for signs of contamination (e.g. pests, insects, rodent activity including faeces and urine, mould, foreign material and lubricants).
  • The manufacturer has specifications and procedures in place to properly identify and control returned product.
  • The manufacturer maintains a list of acceptable suppliers based on a documented history of adherence to specifications.

Note: Establishments requiring additional information on importing chocolate or other ingredients should refer to the Good Importing Practices (GIP) document on the CFIA website.

Refer to Health Canada's Compendium of Analytical Methods for microbiological guidelines for chocolate.

See Section 1.11.1 Verification Procedures of this guidance document for information regarding sampling and analysis of incoming ingredients.

See Section 1.1.4 Food Additives of this guidance document for information to assess specifications for food additives.

See Section 7.2.2 for expected incoming material control records.

Non-Conforming Ingredients

When ingredients fail to meet specifications that impact food safety, the manufacturer investigates and identifies the root cause. The manufacturer initiates corrective action by determining whether food safety is compromised and by taking the necessary actions. See Section 1.10 – Deviations and Corrective Action and Section 7.2.5 – Deviations and Corrective Action Records.

1.4.2 Packaging Materials

The manufacturer controls incoming packaging materials to meet the requirements of Division 23 of the Food and Drug Regulations, such that no biological, physical or chemical hazards result in the food.

Rationale

Controls are necessary to ensure that packaging materials meet the manufacturer's specifications. Inadequate controls could result in the use of containers that may contaminate the product, or may permit physical, chemical or biological contamination of the product.

Anticipated Outcomes
  • The manufacturer demonstrates that the packaging material is appropriate for the intended use and is used in accordance with the packaging manufacturer's instructions. The appropriateness of packaging material will vary with the product and process and the associated contamination risks.
  • The manufacturer has written specifications for packaging materials that identify criteria essential for the manufacturing process and product safety.
  • Each lot of packaging material is examined for physical damage, signs of contamination (e.g. stains, bird droppings, rodent activity [e.g. faeces, urine] and insects) and foreign material (e.g. wood, metal, glass) at receiving. The manufacturer does not use contaminated or potentially contaminated packaging material

See Section 7.2.2 for expected Incoming Material Control Records.

1.5 Packaging Control

1.5.1 Packaging

Handling and use of packaging is controlled to prevent product contamination.

Rationale

Inadequate control of packaging materials may result in the use of damaged, defective or contaminated packaging, which may lead to contamination of the product.

Anticipated Outcomes
  • The manufacturer has an effective system in place to prevent the use of contaminated, damaged or defective containers (e.g. receiving and storage controls, visual examination prior to use).
  • Only packaging materials required for immediate use are kept in the packaging or filling area.
  • Packaging is performed under hygienic conditions that preclude the introduction of contamination into the product.
  • Containers are used only for their intended purpose.

1.6 Product Preparation/Blending

1.6.1 Control of Preparation, Composition and Blending

Factors significant to food safety in the formulation, which may be CCPs, are controlled during preparation and blending to minimize physical, chemical and biological hazards, and to ensure accuracy of composition.

Rationale

Inadequate control of factors associated with product preparation/blending could result in inadequate processing or the presence of undeclared allergens. The product may violate permissible levels of food additives or may fail to meet compositional standards, and/or the product's nutrient content declaration may be inaccurate.

Anticipated Outcomes
  • The manufacturer has controls in place to prevent hazards associated with the preparation or blending of the product. Areas significant to food safety are outlined below.
  • The manufacturer monitors factors significant to food safety and/or Critical Control Points (under a HACCP System) at a scheduled frequency. For further information regarding Critical Control Point rationale see Appendix A and the CFIA HACCP Generic Model for Moulded Dark Chocolate with Almonds.
Allergens

The manufacturer has controls in place to prevent the presence of undeclared allergens. Allergens are ingredients that can elicit an allergic response in sensitive individuals. Areas that may require control include:

  • cross-contamination or carry-over;
  • inappropriate use of rework;
  • ingredient changes, substitutions or additions, changes to the components of ingredients;
  • incorrect labels;
  • incorrect or incomplete list of ingredients; and
  • unknown ingredients (e.g. ingredients purchased from a new supplier and without specifications).

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens, guidance on the Labelling of Foods Causing Allergens and Sensitivities, a Tool for Managing Allergen Risk in Food Products, and Food Allergies and Allergen Labelling.

Food Additives

The manufacturer has controls in place to ensure that the food additives that are used are permitted, and are used within allowable levels. Specifically, controls ensure:

  • clear identification of additives;
  • accurate measurement;
  • adequate blending for homogeneity; and
  • checks against unauthorized substitution.
Composition

The manufacturer has controls in place to ensure the composition of the product accurately reflects the formulation. Manufacturers may require controls to prevent the following:

  • misdirection of ingredients;
  • inappropriate use of rework;
  • ingredient carryover;
  • inappropriate ingredient substitutions;
  • carryover from equipment (e.g. product changeovers).

See Section 7.2.3 for expected product preparation/blending records.

1.6.2 Cleaning/Sorting – Contamination Control

Raw materials and ingredients are cleaned, sorted, and/or inspected in such a manner as to reduce biological, physical and chemical contamination and to prevent contamination of the finished product.

Rationale

Adequate cleaning, sorting and/or inspection of raw materials and ingredients (e.g. tree nuts, peanuts and raisins) are necessary to prevent, reduce or remove contamination of a biological, chemical and/or physical nature.

Anticipated Outcomes
  • The manufacturer screens ingredients as necessary to address any biological, chemical or physical risks. The extent of this activity will vary depending on a manufacturer's specifications and control over incoming raw materials and ingredients to eliminate potential hazards.
  • Visual inspection can identify physical hazards (e.g. hazardous extraneous material, such as shells, stones and metal), as well as visible signs of damage that could indicate possible biological or chemical contamination.
  • Use of screens, magnets and/or metal detectors can reduce the risk from hazardous extraneous material in tree nuts, peanuts, raisins and melted chocolate.

Note: Refer to the CFIA's Reference Database for Hazard Identification for more hazard information.

Refer to Section 1.8.1 Processing Controls for details on cutting/breaking, melting & tempering, screening, magnets, mixing & blending, depositing & moulding, cooling, demoulding, rework and metal detectors.

1.7 Product Coding Control

1.7.1 Product Coding

Pre-packaged chocolate products are identified with code marks or lot numbers on the label or container to allow the identification of product in the event of a recall.

Rationale

Coding control permits products to be traced through the distribution chain and could provide manufacturing details.

Note: Coding is not a mandatory labelling requirement, however, this practice is recommended under Section 8.2.1 (Recall Procedure) to enhance the effectiveness of a recall.

Anticipated Outcomes
  • The manufacturer ensures that pre-packaged chocolate products are permanently marked with a legible code or lot identification on the label, the package or container.
  • The coding system identifies where the product was manufactured (facility, line, etc.) and when (shift, day, month, year, etc.).
  • The exact meaning of all code marks used is available from the manufacturer.
  • Where used, case codes are legible and correspond to the identifying marks on the product within.

1.8 Process Control

1.8.1 Processing Controls (Cutting/Breaking, Melting & Tempering, Screening, Magnets, Mixing & Blending, Depositing & Moulding, Cooling, Demoulding, Rework and Metal Detectors)

All processing factors are controlled to ensure the safety of the product.

Rationale

Inadequate control of processing factors could result in biological, chemical or physical hazards.

Anticipated Outcomes
  • The manufacturer evaluates the process and identifies all factors that have an impact on the safety of the final product.
  • The manufacturer ensures all appropriate processing factors are controlled within acceptable limits.
  • The manufacturer monitors factors significant to food safety and/or Critical Control Points at a scheduled frequency.
  • With respect to food allergen control:
    • wherever possible dedicated lines are used.
    • if common equipment is used for products with allergens and those without, the process does not result in undeclared allergens.
    • the manufacturer has established and verified procedures for product changeover that does not result in undeclared allergens.
    • the process flows from incoming materials to the finished product with no cross-overs or other areas that can cause undeclared allergens (e.g. conveyor belts, shared equipment).
Common Processing Steps and Controls
  • Cutting/Breaking
    • Handling of chocolate is conducted in a hygienic manner to avoid contamination of chocolate as it is broken into manageable pieces before melting.
    • Utensils and equipment used for cutting and/or breaking are clean, acceptable for food contact, and maintained in good operating condition to minimize the potential for physical contamination of the product with metallic extraneous material.

    Note: See Section 2.1.3 Equipment Maintenance and Calibration Program for further information relating to the maintenance of equipment.

  • Melting & Tempering
    • To prevent the occurrence of undeclared allergens in food products, chocolate (e.g. dark, milk or white) is melted and tempered as per formulations and recipes. Caution is exercised to ensure rework and/or returned products are only added to end products containing the same allergens (e.g. peanuts, almonds and/or milk ingredients).
    • Water-jacketed melting, tempering and holding tanks are maintained in good operating condition to minimize the contamination of chocolate with water as the presence of water may permit the growth of pathogenic microorganisms. Agitators used in tanks are maintained in good operating condition to minimize contamination with hazardous extraneous material. Melting, tempering and holding tanks are adequately covered to minimize contamination.
  • Screening
    • Screening operations are controlled to reduce or eliminate physical hazards. Screening equipment is maintained in good operating condition to minimize the contamination of chocolate with hazardous extraneous material. Screening equipment is cleaned and inspected regularly to ensure proper function (torn screens are repaired, etc.). Hazardous extraneous material captured by the screening equipment is examined to determine the source and follow-up is conducted as necessary.
  • Magnets
    • Magnets are situated inline so that all product must pass over them. They are checked and cleaned regularly (at the beginning and end of product at a minimum).
    • Objects captured by the magnets are examined to identify their source and follow-up is conducted as necessary.

    Note: See Section 2.1.4 Instrumentation Maintenance and Calibration Program for further information relating to the maintenance and calibration of magnets.

  • Mixing & Blending
    • Ingredients are added as per mixing and blending formulations and/or recipes. Adjustments to formulations and/or recipes are confirmed by qualified personnel.
    • Mixing and blending equipment is maintained in good operating condition to minimize the contamination of chocolate with extraneous material or lubricants. Ingredients are added in a hygienic manner.
  • Depositing & Moulding
    • Moulds used in the process have been adequately cleaned. Following sanitation, moulds are adequately protected to prevent contamination prior to depositing.
    • Moulds are of sound condition, free of cracks and dents and are handled to prevent damage to minimize the likelihood of physical contamination.
    • Moulds are constructed of material that is easy to clean and are able to withstand the demands of the operation without contributing to the physical contamination of the product.
    • The moulding or depositing area is adequately protected to minimize the potential of physical contamination.
  • Cooling
    • Air used for the cooling of products is acceptable for direct food contact.
    • Air filters, when used, are frequently examined (visually) to ensure their integrity and effectiveness.
    • Cool surfaces in warm areas are insulated to prevent any formation of condensate. Insulation is kept in sound condition.
    • Cooling tunnels are adequately protected to minimize the potential for physical contamination.
    • Equipment is maintained in good operating condition to minimize the potential contamination of chocolate products from leaking cooling agents.
  • Demoulding
    • Demoulding is performed in a hygienic manner using equipment of sound condition and is performed in a manner that does not compromise the integrity of moulds leading to the possible contamination of the product.
  • Rework
    • In-process materials considered acceptable for rework are collected, handled and stored in a hygienic manner to avoid contamination.
    • Rework in containers is clearly identified, including composition and batch identification.
    • Rework is controlled to ensure like products are added to like products (i.e. contains the same allergens) that declare the allergen.
  • Metal Detectors
    • The metal detector functions as intended when metal is detected (e.g. line stops, alarm sounds or product is ejected from the line).
    • Proper functioning is monitored by passing test wands (ferrous, non-ferrous and stainless) through the detector at an established frequency.

    Note: See Section 2.1.4 Instrumentation Maintenance and Calibration Program for further information relating to the maintenance and calibration of metal detectors.

See Section 7.2.4 for expected Process Control Records.

1.9 Labelling Control

1.9.1 Prevention of Mislabelling

The manufacturer has controls in place to prevent mislabelling.

Rationale

Control of labelling is important to ensure that the correct label is applied to each product. Use of incorrect labels could mislead the consumer and could pose a potential health hazard to people with allergies (e.g. milk, tree nut, peanut).

Anticipated Outcomes

The manufacturer has procedures in place to ensure that the correct label is applied to the correct product. Typical controls are listed below.

  • Procedures are in place to ensure the product being supplied or added to the labelling operation corresponds to the labels in use (e.g. on-line checks to ensure that products are correctly labelled).
  • Product types are effectively separated during changeovers (e.g. appropriate breaks between products, visual inspection to ensure products are not mixed prior to labelling).
  • Different product labels or pre-labelled packaging are effectively separated, and the number of product label types is kept to a minimum.
  • Identifying marks and/or colours are utilized on labels to ensure correct labels are being loaded into the labeller or manually applied on the product.
  • At a minimum, tops and bottoms of label bundles are visually checked for mixed labels prior to use. Similarly, pre-labelled packages are also visually checked prior to use.
  • During storage, care is taken to prevent mixing of individual labels, bundles of labels and pre-labelled packages (e.g. labels and/or pre-labelled packages are stored in separate boxes, no labels or pre-labelled packages are loose, unused labels or pre-labelled packages are returned to the correct boxes).
  • Corroborate the product label information with the following data: recipes, including processing aids, components of ingredients, composition of reworked products and composition of food packaging.

Note: The CFIA website contains information and guidance for the food industry regarding food allergens, including more information on Canada's priority allergens, guidance on the Labelling of Foods Causing Allergens and Sensitivities, a Tool for Managing Allergen Risk in Food Products, and Food Allergies and Allergen Labelling.

1.10 Deviations and Corrective Action

1.10.1 Deviation Control

When critical limits or limits of acceptability are exceeded or defects occur which could affect product safety or composition, procedures are in place to identify, isolate and evaluate products.

Rationale

Deviations from critical limits, limits of acceptability and procedures, or the occurrence of defects, may affect the safety of the product. Inadequate deviation procedures or non-adherence to procedures could result in the sale of unsafe product or misrepresented product.

Note: Deviation procedures apply to all sections of this guidance document, where appropriate.

Anticipated Outcomes

The manufacturer has a pre-determined and documented deviation procedure designed to identify deviations in either the product and/or the procedures, isolate defective products and take appropriate corrective actions.

Identification of Deviation

The manufacturer has a system in place to identify deviations when they occur.

Isolation of Affected Product
  • The manufacturer has effective procedures in place to isolate, clearly mark and control all product manufactured during the deviation period.
    • All unsatisfactory product is isolated back to the point where the process was last in control. This could be beyond the last satisfactory record.
    • Isolated product is clearly marked (e.g. firmly attached tags contain the following information: hold number, product, the amount, the date held, the reason for the hold, and the name of the person holding the product).
    • The manufacturer maintains control of the product from the hold date to the date of final disposition.
Evaluation of Affected Product
  • Product evaluation is conducted by a qualified person.
  • Action on affected product (e.g. returning unused ingredients/materials to the supplier, sorting of suspect lots, re-processing, disposal) is conducted in an appropriate manner by adequately trained personnel.
  • Evaluation is adequate to detect potential health hazards, or to identify misrepresentation. For example:
    • sampling is adequate to identify the extent of the problem;
    • tests are appropriate;
    • judgement is based on sound science; and
    • the product is not released until the evaluation has determined that no health hazard exists and the product is in compliance with appropriate legislation.

See the HACCP Generic Model for Moulded Dark Chocolate with Almonds for suggested deviation procedures and corrective actions.

1.10.2 Corrective Action

Corrective action taken following any deviation is effective to rectify and to prevent recurrence of the deviation.

Rationale

Corrective action procedures are necessary to determine the cause of the problem and to take action to prevent recurrence. It is essential to follow-up any corrective action with monitoring and reassessment to ensure that the correction has been effective.

Anticipated Outcomes
  • As part of the deviation procedure, the manufacturer has a set of documented corrective actions that include:
    • an investigation to determine the cause of the deviation;
    • preventive measures taken to prevent recurrence of the deviation; and
    • verification by the manufacturer of the effectiveness of the corrective action and preventive measures taken.

See the HACCP Generic Model for Moulded Dark Chocolate with Almonds for suggested deviation procedures and corrective actions.

See Section 7.2.5 for expected Deviations and Corrective Action Records.

1.11 Verification of Product Safety

1.11.1 Verification Procedures

The manufacturer uses supplementary methods of evaluation to verify the conformance and effectiveness of controls affecting product safety.

Rationale

The purpose of verification is to assess the conformance and effectiveness of existing controls in preventing health hazards and to indicate areas where improvements are required.

Note: Verification applies to all sections of this guidance document, where appropriate.

Anticipated Outcomes
  • The manufacturer verifies the conformance and effectiveness of controls affecting product safety.
  • Individuals or organizations responsible for verification are identified. These individuals or organizations are suitably qualified.
  • The verification frequency and methods are appropriate to the hazards associated with the product and process.
  • Methods of verification may include the following:
    • review of all specifications for incoming ingredients and materials as well as Letters of Agreement at an adequate frequency and/or whenever any changes are made;
    • manufacturers testing incoming lots of chocolate use statistically valid sampling methods for the detection of Salmonella spp. in chocolate;
    • sampling and analyses of in-process and finished product for the appropriate biological hazard (e.g. Salmonella spp., Coliform, and Aerobic Colony Count [ACC] includes aerobic sporeformers), chemical hazard (e.g. Allergen detection test) or physical hazard;
    • refer to Health Canada's Compendium of Analytical Methods, volume 1 for microbiological standard (B.04.012, FDR) and guidelines for chocolate.
      Note: analysis for pathogenic microorganisms should be performed in a separated or external test laboratory to avoid the potential for cross-contamination.
    • microbiological environmental sampling of food contact and non-food contact surfaces in processing areas to identify biological hazards (e.g. Salmonella spp., coliforms and ACC including aerobic sporeformers);
    • chemical environmental sampling of food contact and non-food contact surfaces in processing areas to identify chemical hazards (e.g. allergens);
    • ensure that employees adhere to sampling programs if applicable;
    • on-site assessment of the monitoring procedures (e.g. GMPs and Critical Control Points);
    • review of records for completeness;
    • review of deviation records to ensure that appropriate corrective actions and preventive measures are taken and recorded in the event of a deficiency;
    • independent external or internal audits; and/or
    • analysis of consumer complaint trends.

See Section 7.2.6 for expected Verification Record.

Chapter 2 : Equipment

2.1 General Equipment

2.1.1 Design, Construction and Installation

All equipment and utensils are designed, constructed and installed to function as intended, to permit effective cleaning and sanitation and to prevent contamination of chocolate.

Anticipated Outcomes
  • Equipment is designed, constructed and installed to ensure that:
    • the process is capable of delivering the required results;
    • it can be adequately and easily cleaned, sanitized, maintained and inspected to prevent contamination of the product during operations (e.g. equipment, including bypass lines, is designed to prevent dead spaces where residue and moisture (from sanitation) may accumulate and be difficult to remove with regular sanitation procedures);
    • contamination of the product during operation is prevented (e.g. location of lubricant reservoirs);
    • equipment is exhausted to the outside to prevent excessive condensation where necessary;
    • proper drainage is permitted and where appropriate, equipment is connected directly to drains. Where applicable, drains are fitted with backflow preventers;
    • dust control devices are used to collect and remove particulate matter from the processing area for ingredients that generate dust;
    • storage tanks and hoppers are adequately covered;
    • cool surfaces in warm areas are insulated to prevent the formation of condensate. The insulation is maintained in sound condition;
    • cooling tunnels have access portals to permit visual control and access to permit effective cleaning.

2.1.2 Food Contact Surfaces

Food contact surfaces are constructed of appropriate materials and are maintained in a manner to prevent the contamination of foods.

Anticipated Outcomes
  • Food contact surfaces of equipment, moulds, trays, containers and utensils are smooth, non-corrosive, non-absorbent, non-toxic, free from pitting, cracks or crevices, and able to withstand repeated cleaning and sanitation (e.g. non-wooden equipment is used).
  • When coatings, paints, chemicals, lubricants and other materials are used for food contact surfaces or utilized on equipment where there is a possibility of contact with food, the substances are appropriate for the intended use and are used in accordance with the manufacturer's instructions.
  • Equipment and utensils used to handle inedible material are not used to handle edible material.

2.1.3 Equipment Maintenance and Calibration Program

An effective maintenance and calibration program is in place to ensure that equipment performs consistently as intended and prevents contamination of the product.

Anticipated Outcomes
  • The manufacturer has an effective written preventive maintenance and calibration program to ensure that equipment that may impact on food safety functions as intended. This includes:
    • a list of equipment requiring regular maintenance; and
    • the maintenance procedures and frequencies (e.g. equipment inspection instructions, a schedule of adjustments and part replacements based on the equipment manufacturer's manual or equivalent, or based on operating conditions that could affect the condition of the equipment).
  • The manufacturer establishes written protocols, including calibration methods and frequencies, for equipment monitoring and/or controlling devices that may impact on food safety.
  • Equipment is maintained in a manner which ensures that there is no potential for the development of physical or chemical hazards (e.g. hazards resulting from inappropriate repairs, flaking paint and rust, excessive lubrication).
  • Maintenance and calibration of equipment is done by appropriately trained personnel.
  • When routine or emergency repairs are made to equipment, in direct or indirect contact with food, an inspection to assess the compliance of the repair is performed before the equipment is used.
  • The preventive maintenance and calibration programs and written protocol are adhered to.

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

2.1.4 Instrumentation Maintenance and Calibration Program

Instrumentation is designed, constructed, installed, calibrated and maintained such that the equipment is capable of delivering the required process, thereby ensuring product safety.

Rationale

Improper design, installation, calibration or maintenance of instruments can lead to inadequate processing of the product, or to misuse of food additives.

Anticipated Outcomes
  • The manufacturer has an effective written preventive maintenance and calibration program to ensure that instrumentation which may impact on food safety functions as intended. This includes:
    • a list of instrumentation requiring regular maintenance and calibration; and
    • the maintenance and calibration procedures and frequencies.
  • Instruments which control factors that may have an impact on food safety are designed, installed, constructed, calibrated and maintained as necessary to ensure that they function as intended.
  • Maintenance and calibration of instruments is done by appropriately trained personnel.
  • The preventive maintenance and calibration programs and written protocol are adhered to.

The following are some examples of instrumentation that may be required to control factors significant to the process:

Temperature Measuring Devices
  • The manufacturer uses one temperature scale consistently throughout the processing system (e.g. Celsius or Fahrenheit).
  • Temperature measuring devices are calibrated against a known standard just prior to installation, and thereafter, a minimum of once per year (or more frequently as recommended in the equipment manufacturer's manual), and are maintained as necessary to ensure accuracy.
Metal Detectors

Metal detection equipment is designed, constructed, installed, calibrated and maintained in accordance with the equipment manufacturer's manual, to ensure effective removal of metals. This may include adjustment for product effect, selection of target metal and size, timing of the reject mechanism and suitability for environmental conditions.

Magnets
  • The strength and type of magnets are appropriate to the use.
  • Magnets are installed in a manner to effectively remove ferrous metal prior to, or after, certain operations.
  • The strength of magnets is confirmed with the use of probes or other effective devices as necessary.
  • Magnets are monitored as necessary to ensure effective operation and surface exposure (e.g. adequately cleaned, metal particles removed).
Other Instrumentation

When other specialized instrumentation, such as electronic devices or temperature recorders, is used to control factors significant to food safety, they are calibrated as necessary.

Note: The manufacturer initiates corrective action as per Section 1.10 Deviations and Corrective Action when critical limits or limits of acceptability are exceeded, or whenever products could have been affected and found not to meet specifications.

See Section 7.3.1 for expected Equipment/Instrumentation Maintenance and Calibration Records.

Chapter 3: Premises

3.1 Building Exterior

3.1.1 Outside Property and Buildings

Buildings and surrounding areas are designed, constructed and maintained in a manner which prevents conditions that may result in the contamination of food.

Anticipated Outcomes
Grounds, Roadways and Drainage
  • The surrounding land is maintained to control sources of contamination such as debris and pest harbourage areas.
  • The building is not located in close proximity to any environmental contaminants.
  • Roadways are properly graded, compacted, dust-proofed and drained.
  • The surrounding property is adequately drained.
Exterior Building Structure

The building exterior is designed, constructed and maintained to prevent entry of contaminants and pests. For example, the exterior has no unprotected openings; air intakes are appropriately located; and the roof, walls and foundation are maintained to prevent leakage.

3.2 Building Interior

3.2.1 Design, Construction and Maintenance

Building interiors and structures are designed, constructed and maintained so as to prevent conditions that may result in the contamination of food.

Anticipated Outcomes
Floors, Walls and Ceilings
  • Floors, walls and ceilings are constructed of materials that are durable, impervious, smooth, cleanable, and suitable for the production conditions in the area (i.e. materials will not result in the contamination of the environment or food).
  • Where appropriate, wall, floor and ceiling joints are sealed and angles are covered to prevent contamination and facilitate cleaning.
  • Floors are sufficiently sloped to permit liquids to drain to trapped outlets.
  • Ceilings, overhead structures, stairs and elevators are designed and constructed to prevent contamination.
  • Floors, walls, ceilings and all overhead structures are maintained to prevent deterioration (e.g. rust, flaking paint) and contamination (e.g. dust, mould).
Windows and Doors
  • Windows are sealed or equipped with close-fitting insect screens.
  • Where there is a likelihood of breakage of glass windows that could result in the contamination of food, the windows are constructed of alternative materials or are adequately protected;
  • Doors have smooth, non-absorbent surfaces and are close-fitting to prevent entry of pest and vermin and self-closing where appropriate.
Process Flow Separation
  • Buildings and facilities are designed to facilitate hygienic operations (i.e. there is regulated flow in the process, from the arrival of the raw material at the premises to the finished product).
  • Raw materials are isolated from other plant operations.
  • Activities are adequately separated by physical or other effective means where cross-contamination (e.g. biological, chemical, allergens) may result. For example:
    • all untreated raw materials are kept separate from finished products to prevent microbiological cross-contamination.
    • potential allergens are controlled to avoid the possibility of cross-contamination.
  • It is preferred that dedicated processing line equipment, moulds and utensils are used for allergen containing products.
  • Where common pieces of equipment are used for the processing of allergen containing products and non-allergen containing products, the manufacturer has established a procedure that does not result in the contamination of food products with allergens.
  • The manufacturer has established a process flow from incoming materials to the finished products with no cross-overs or other areas that can cause undeclared allergens (e.g. conveyor belts, shared equipment).
  • Where mobile equipment (such as hand trucks or fork lifts) moves between incompatible areas, measures are taken to minimize cross-contamination.
  • Pallet design, condition and use are specified to avoid contamination.

3.2.2 Lighting

Lighting is adequate for the activity being conducted. Where appropriate, light bulbs and fixtures are protected to prevent contamination of food or packaging material.

Anticipated Outcomes
  • Lighting is appropriate such that the intended production or inspection activity can be effectively conducted. The lighting does not alter food colour and is not less than the following;
    • 540 lux (50 foot candles) in inspection areas (Inspection areas are defined as any point where the food product or container is visually inspected or instruments are monitored.);
    • 220 lux (20 foot candles) in work areas;
    • 110 lux (10 foot candles) in other areas.
  • Light bulbs and fixtures located in areas where there is exposed food and packaging material are of a safety type or are protected to prevent contamination of food and packaging material in case of breakage (e.g. shatterproof bulbs or bulb covers).

3.2.3 Ventilation

Adequate ventilation is provided to prevent excessive heat, steam, condensation and dust, and to minimize entry of contaminated air. Air used for processing techniques is appropriately sourced and treated.

Anticipated Outcomes
  • Ventilation provides sufficient air exchange to prevent unacceptable accumulations of steam, condensation, dust or excessive heat and to minimize entry of contaminated air.
  • Ventilation systems are constructed to avoid airflow from contaminated areas (e.g. the receiving area) to clean areas (e.g. packaging and finished product storage) and designed to be adequately maintained and cleaned.
  • Ventilation openings are equipped with close-fitting screens or filters as appropriate to prevent the intake of contaminated air (dust, dirt) or entry of insects and rodents. Air filters (e.g. filters for intake air and compressed air) are checked, cleaned or replaced at least as often as the manufacturer specifies or more frequently if a problem is indicated, such as evidence of filter fouling or perforation.
  • Air used as a processing technique which comes in contact with food (e.g. pneumatic instrumentation or air blowers) is appropriately sourced and treated (e.g. air intakes, filters, compressors) to reduce any source of contamination.

3.2.4 Waste Disposal

Sewage, effluent and waste storage and disposal systems are designed, constructed and maintained to prevent contamination.

Anticipated Outcomes
  • Drainage and sewage systems are equipped with appropriate traps and vents.
  • Establishments are designed and constructed so that there is no cross-connection between the sewage system and any other waste effluent system in the establishment.
  • Effluent or sewage lines do not pass directly over or through production areas unless they are controlled to prevent contamination.
  • Adequate facilities and equipment are provided and maintained for the storage of waste and inedible material prior to their removal from the establishment. These facilities are designed to prevent contamination.
  • Containers used for waste are clearly identified, leakproof, moisture resistant, easy to clean and, where appropriate, covered.
  • Waste is removed and containers are cleaned and sanitized at an appropriate frequency to minimize the potential for contamination.

3.3 Sanitary Facilities

3.3.1 Employee Facilities

Employee facilities are designed, constructed and maintained to permit effective employee hygiene and to prevent contamination.

Anticipated Outcomes
  • Processing areas are provided with an adequate number of conveniently located hand-washing stations (preferably hands-free) with trapped waste pipes to drains.
  • Washrooms, lunchrooms and change rooms are adequately ventilated and maintained in a clean condition. They are separate from and do not lead directly into food processing areas.
  • Washrooms have hand wash facilities with a sufficient number of maintained sinks that are properly trapped to drains.
  • Toilet facilities are maintained in good repair at all times.
  • Handwash facilities are adequately maintained and have hot and cold running potable water distributed from a single nozzle, soap, sanitary hand-drying supplies or devices, and, where required, a cleanable waste receptacle.
  • Handwash stations, hand dips and footbaths are maintained in all applicable areas of the facility.
  • Notices to wash hands are posted in appropriate areas.

3.3.2 Equipment Cleaning and Sanitizing Facilities

Facilities for cleaning and sanitizing equipment are adequately designed, constructed and maintained to prevent contamination.

Anticipated Outcomes
  • Facilities are constructed of corrosion resistant materials which are capable of being easily cleaned, and are provided with potable water at temperatures appropriate for the cleaning chemicals used.
  • Equipment cleaning and sanitizing facilities are adequately separated from food storage, processing and packaging areas, to prevent contamination.

3.4 Water and Steam Quality

3.4.1 Water

The potability of hot and cold water is controlled to prevent contamination.

Anticipated Outcomes
  • Potable water meets the requirements of Health Canada's Guidelines for Canadian Drinking Water Quality and any applicable provincial and municipal requirements. Water is analysed by the chocolate manufacturer at a frequency adequate to confirm its potability. For microbial analysis, water from a municipal water source is analysed semi-annually and water from other sources is analysed on a monthly basis. For chemical analysis, water from non-municipal sources is adequately analysed at the initial start-up of the well, as a minimum.
  • Chocolate manufacturer has contingency plans in place to deal with provincial/municipal orders to boil water and unsatisfactory water analysis results.
  • There are no cross-connections between potable and non-potable water supplies and all hoses, taps and other similar sources of potential contamination are designed to prevent back-flow or back-siphonage.
  • Water treatment chemicals, where used, are appropriate for the intended use and are used in accordance with the chemical manufacturer`s instructions.
  • The chemical treatment of water is monitored and controlled to deliver the desired concentration and to prevent contamination.
  • Recirculated water, where used, is treated, monitored and maintained as appropriate to the intended purpose. Recirculated water has a separate distribution system which is clearly identified.
  • Where filters are used they are kept effective and maintained in a sanitary manner.
  • In areas for food processing, handling, packaging and storage, water temperatures and pressures are adequate for all operational and clean-up needs.

See Section 7.4.1 for expected Water/Steam Quality Records.

3.4.2 Steam

The potability of steam which is in direct contact with food or food contact surfaces is controlled to prevent product contamination. Steam supply is adequate to meet operational requirements.

Note: Where steam is not in direct contact with food or food contact surfaces, this section is not applicable.

Anticipated Outcomes
  • Boiler treatment chemicals used are appropriate for the intended use and are used in accordance with the chemical manufacturer`s instructions.
  • Boiler feed water is tested regularly and the chemical treatment is controlled to prevent contamination.
  • The steam supply is generated from potable water and is adequate to meet operational requirements.
  • Traps are provided as necessary to ensure adequate condensate removal and elimination of foreign materials.

See Section 7.4.1 for expected Water/Steam Quality Records.

Chapter 4: Sanitation and Pest Control

4.1 Sanitation

4.1.1 Sanitation Program

An effective sanitation program for equipment and premises is in place to prevent contamination of food.

Note: The sanitation program may be a combination of wet and dry cleaning procedures; however, this type of sanitation program may not be sufficient to control the possibility of cross-contamination from allergens.

With respect to allergen control, if dedicated equipment is not used for non-allergen containing products, the sanitation program should be performed in a manner to prevent the possibility of cross-contamination from allergens.

Anticipated Outcomes
  • The chocolate manufacturer has a written cleaning and sanitation program for all equipment which includes:
    • the responsible person;
    • the frequency of the activity;
    • the chemicals and concentrations used;
    • the temperature requirements;
    • the procedures for cleaning and sanitizing that:
      1. identify lines, equipment and utensils;
      2. outline disassembly/reassembly instructions as required for cleaning and inspection;
      3. identify areas on equipment requiring special attention (e.g. dead spots where residue may accumulate);
      4. outline the method of cleaning, sanitizing and rinsing.
    • the type and frequency of inspection to verify the effectiveness of the program.
  • Cleaned equipment is properly protected and/or stored to maintain in a sanitary condition.
  • The chocolate manufacturer has a written cleaning and sanitation program for the premises (production and storage areas) which specifies areas to be cleaned, the method of cleaning, the person responsible and the frequency of the activity. Special sanitation and housekeeping procedures required during production are specified within the document (e.g. removal of product residues during breaks).
  • Chemicals are appropriate for the intended use and are used in accordance with the chemical manufacturer's instructions.
  • Cleaning and sanitizing equipment is designed for its intended use and is properly maintained.
  • The sanitation program is carried out in a manner that does not contaminate food or packaging materials during, or subsequent to, cleaning and sanitizing (e.g. no contamination by aerosols or chemical residues).
  • Policy is in place to ensure that unscheduled, emergency repairs or maintenance to processing equipment or building interior (e.g. walls, ceilings, plumbing) is followed by thorough cleaning and sanitizing.
  • Effectiveness of the sanitation program, including cleaning following emergency repairs, is monitored and verified (e.g. by a pre-operational inspection of premises and equipment, where appropriate, by microbiological sampling and allergen testing) and where necessary, the program is adjusted accordingly.
  • The sanitation program is adjusted as necessary to incorporate new cleaning procedures (e.g. new equipment, new chemicals).
  • Operations begin only after sanitation and drying requirements have been met. For establishments performing a wet wash, water is thoroughly removed prior to the start of production to minimize microbial growth.

See Section 7.5.1 for expected Sanitation Records.

4.2 Pest Control

4.2.1 Pest Control Program

Effective pest control programs are in place to prevent entry of pests, to detect and eliminate pests and to prevent the contamination of food.

Anticipated Outcomes
  • There is an effective written pest control program for the premises and equipment that includes:
    • the person to whom the manufacturer assigned responsibility for pest control;
    • where applicable, the name of the pest control company or the name of the person contracted for the pest control program;
    • the list of chemicals used, the concentration, the location where they were applied, and the method and frequency of application;
    • a map of trap locations;
    • the type and frequency of inspection carried out to verify the effectiveness of the program.
  • Pesticides used are registered with the Pest Management Regulatory Agency under the Pest Control Products Act and Regulations and have been issued a PCP Registration Number. Pesticides are used in accordance with the label instructions.
  • Chemical treatment of equipment, premises or ingredients to control pests is conducted in a manner to ensure that the maximum residue limit of the Food and Drugs Act and Regulations is not exceeded (e.g. the number of fumigation treatments per lot is limited).
  • Poisonous rodenticides are not used in food processing or storage areas.
  • Birds and animals are excluded from establishments.

See Section 7.5.2 for expected Pest Control Records.

Chapter 5: Personnel

5.1 Hygiene and Health Requirements

5.1.1 Cleanliness and Conduct

All persons entering food handling areas maintain an appropriate degree of personal cleanliness and take the appropriate precautions to prevent the contamination of food.

Anticipated Outcomes
  • All persons wash and sanitize their hands upon entering food handling areas, before starting work, after handling contaminated materials (e.g. picking objects off the floor, handling garbage, cleaning chemicals or raw incoming materials), after breaks, after using toilet facilities or after blowing their nose and whenever there is a risk of contamination of the products. Fingernails are kept clean without nail polish.
  • Disposable gloves are changed whenever contamination is a possibility.
  • Protective clothing, hair and/or beard covering, footwear and/or gloves appropriate to the operation in which the employee is engaged, are worn and maintained in clean and sanitary manner.
  • Any behaviour which could result in contamination of food, such as eating, drinking, use of tobacco, gum chewing or unhygienic practices such as spitting, are prohibited in food handling areas.
  • All persons entering food handling areas remove jewellery and other objects which may fall into or otherwise contaminate food. Jewellery which cannot be removed, including wedding bands and medical alerts, is covered (e.g. employees wear rubber gloves).
  • For maintenance work in the production areas, strict hygiene standards and precautions are applied to avoid any possible source of contamination.
  • Access of personnel and visitors is controlled to prevent contamination. The traffic pattern of employees prevents cross-contamination of the product (For example, the employees avoid going back and forth to various stages of production. The employees do not go from a potentially contaminated area to the processing and/or packaging area unless they have washed their hands and changed to clean protective clothing.).
  • Personal effects and street clothing are not kept in food handling areas and are stored in a manner to prevent contamination. Only clean protective clothing is worn in packaging and processing areas.
  • Responsibility for ensuring compliance by all personnel with the requirements of this section is specifically allocated to competent supervisory personnel.

5.1.2 Communicable Diseases and Injuries

No person who is known to be infected with a disease likely to be transmitted through food, or who has open cuts or wounds, is permitted to work in food handling areas where there is a likelihood of the person directly or indirectly contaminating the food.

Anticipated Outcomes
  • The manufacturer has and enforces a policy, to prevent personnel from working in food handling areas if they are known to be suffering from a disease, or are known to be carriers of a disease transmissible through food.
  • The manufacturer requires that employees advise management when they are suffering from a communicable disease likely to be transmitted through food. Conditions that are to be reported include:
    • jaundice;
    • diarrhoea;
    • vomiting;
    • fever;
    • sore throat with fever; and
    • discharges from the ear, eye or nose.
  • Employees having open cuts or wounds do not handle food or food contact surfaces unless the injury is completely protected by a secure waterproof covering (e.g. rubber gloves).

5.2 Training

5.2.1 General Food Hygiene Training

Food handlers are trained in personal hygiene and hygienic handling of food, and they understand the precautions necessary to prevent contamination of chocolate.

Anticipated Outcomes
  • The manufacturer has a written training program for employees, and maintains appropriate records.
  • Appropriate training in personal hygiene and hygienic handling of food is provided to all food handlers at the beginning of their employment.
  • Training is reinforced and updated at appropriate intervals, and whenever the employee's duties change.

5.2.2 Technical Training

To ensure food safety, personnel are trained such that they have adequate technical knowledge and understanding of the operation(s) or process(es) for which they are responsible.

Anticipated Outcomes

Training is appropriate to the complexity of the manufacturing process and the tasks assigned. Examples are listed below. The manufacturer has a written training program for employees, and maintains appropriate records.

  • Personnel are trained to understand the importance of the critical factors for which they are responsible; the critical limits and/or company standards; the procedures for monitoring; the action to be taken if the limits and/or standards are not met; and the records to be kept.
  • Managers and supervisors for chocolate manufacturing have the necessary knowledge of food hygiene principles and practices to be able to judge potential risks in order to take the appropriate action necessary to remedy deficiencies.
  • All employees, including maintenance and customer services employees, are trained to implement allergen controls.
  • Operators are trained to have current knowledge of equipment and process technology.
  • Personnel responsible for the maintenance and calibration of equipment impacting on food safety have been appropriately trained to identify deficiencies that could affect product safety, and to take the appropriate corrective action (e.g. in-house repairs, contract repairs). Individuals performing maintenance on specific equipment are appropriately trained.
  • Personnel and supervisors responsible for the sanitation program are appropriately trained to understand the principles and methods required for effective cleaning and sanitizing.
  • Personnel and supervisors responsible for water treatment and water safety monitoring are appropriately trained to understand the principles and methods and are competent in applying procedures designed to protect the safety of food.
  • Personnel who handle potentially hazardous chemicals are instructed in safe handling and disposal techniques.
  • Additional training is provided as necessary to keep knowledge of equipment and processing technology current.
  • Periodic assessments of the effectiveness of training and instruction programs are made as well as routine supervision and checks to ensure that procedures are being carried out effectively.

Chapter 6: Transportation and Storage

Note: If control of incoming materials (Receiving) is included in this chapter (e.g. part of the prerequisite program) the chapter should be re-named Transportation, Receiving and Storage and all of the anticipated outcomes for Sections 1.4.1 and 1.4.2 should be achieved.

6.1 Transportation

6.1.1 Food Carriers

Carriers used by the manufacturer are designed, constructed, maintained, cleaned and utilized in a manner that prevents food contamination.

Anticipated Outcomes
  • Carriers, including bulk tanks, are clean, dry, weatherproof, free of infestation and sealed to prevent water, rodents or insects from reaching the products.
  • Bulk tanks are designed and constructed to permit complete drainage and to prevent contamination.
  • Where direct contact with food may occur, materials used in carrier construction are suitable for food contact.
  • The manufacturer can demonstrate that the carrier has an adequate cleaning and sanitizing program in place (e.g. for bulk carriers, a written cleaning and sanitizing procedure and/or cleaning certificates are available).
  • Carriers are visually inspected by the manufacturer upon receipt of incoming ingredients and prior to loading of final products to ensure they are free from contamination and suitable for the transportation of food.
  • Proper environmental conditions are controlled, monitored, and documented to assure raw material and finished product safety and wholesomeness.
  • Carriers are loaded, arranged and unloaded in a manner that prevents damage and/or contamination of the food.
  • Where the same carriers are used for food and non-food loads, procedures are in place to restrict the type of non-food loads to those that do not pose a risk to food loads in the same shipment, or to subsequent food loads after an acceptable clean out.

6.1.2 Temperature Controls

Ingredients are transported in a manner designed to prevent temperature abuse that could result in deterioration of the product and affect its safety.

Anticipated Outcomes
  • Ingredients, other than chocolate, requiring refrigeration are transported at 4°C (39°F) or less and the temperature is appropriately monitored.

6.2 Storage

6.2.1 Incoming Materials Storage

Storage and handling of incoming ingredients and packaging materials is controlled to prevent damage and contamination.

Anticipated Outcomes
  • Humidity sensitive ingredients are stored under appropriate environmental conditions to prevent deterioration.
  • Ingredients requiring refrigeration are stored at 4°C or less and are appropriately monitored.
  • Incoming materials and packaging materials are handled and stored in a manner that prevents damage and/or contamination (including cross-contamination with allergens).
  • Incoming materials containing allergens are clearly identified (using a color code or other identification system).
  • Incoming materials and packaging materials are stored off the floor and away from walls to permit access for cleaning and pest control.
  • All raw materials are kept separate from packaging materials or finished product.
  • Stock rotation (of ingredients and where appropriate, packaging materials) is controlled to prevent deterioration and spoilage (i.e. first-in, first-out).
  • Defective or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

6.2.2 Non-Food Chemicals – Receiving and Storage

Non-food chemicals are received and stored in a manner that prevents contamination of food, packaging materials and food contact surfaces.

Anticipated Outcomes
  • Non-food chemicals are received and stored in a dry, well ventilated area.
  • Non-food chemicals are stored in designated areas such that there is no possibility for cross-contamination of food or food contact surfaces.
  • Where required for ongoing use in food handling areas (e.g. conveyor lubricants), these chemicals are stored separate from food and located in a manner that prevents contamination of food, food contact surfaces or packaging materials.
  • Non-food chemicals are stored and mixed in clean, correctly labelled containers that include instructions for use.
  • Non-food chemicals are dispensed and handled only by authorized and properly trained personnel.

6.2.3 Finished Product Storage

Finished products are stored and handled under conditions that prevent damage and contamination.

Anticipated Outcomes
  • Finished products are stored and handled under conditions that minimize damage, deterioration and prevent contamination, including cross-contamination with allergens.
  • Finished products are stored off the floor and away from walls to permit access for cleaning and pest control.
  • Stock rotation is controlled to prevent deterioration and prevent spoilage that could present a health hazard.
  • Returned, defective, or suspect product is clearly identified and isolated in a designated area for appropriate disposition.

Chapter 7: Records

7.1 General Records

7.1.1 General Record Requirements

Information is recorded in a manner that represents an accurate history of the product or process. Records are retained for an appropriate period of time.

Anticipated Outcomes
  • Records are legible, permanent and accurately reflect the actual events, conditions or activities.
  • Errors or changes are identified so that the original record remains clear (e.g. strike out with a single stroke and initial the correction/change).
  • Each entry on a record is made by the responsible person at the time that the specific event occurred. The completed records are signed and dated by the responsible person.
  • Critical Control Point records are signed by a qualified individual designated by management. All other records are reviewed at an appropriate frequency to provide an early indication of potentially serious deficiencies.
  • Records are retained for at least one year after the durable life date on the label or container or if there is no durable life date, for at least two years after the date of manufacture.
  • Records are maintained and are available upon request.

7.2 Records on Control of Operation

7.2.1 Process Design Records

Records are kept to demonstrate the adequacy of procedures and methods used in process development.

Rationale

Records are necessary to verify that factors significant to food safety, including Critical Control Points, are adequate in order to produce a safe product.

Anticipated Outcomes

Records are kept which verify that reliable procedures have been followed in designing the process.

7.2.2 Incoming Material Control Records

The manufacturer keeps records that demonstrate the adequacy of incoming materials control.

Rationale

Adequate records are necessary to verify the manufacturer's control over biological, physical and/or chemical hazards associated with incoming materials.

Anticipated Outcomes
Incoming Ingredients

Appropriate records are kept to demonstrate that incoming lots of ingredients were inspected for signs of contamination and adherence to written specifications.

Incoming Packaging Materials

Appropriate records are kept to demonstrate adherence to written specification.

Non-Conforming Incoming Materials (including ingredients and packaging material)
  • The manufacturer has records to:
    • identify the material;
    • identify the deficiency; and
    • specify the preventive measures and corrective actions taken.

7.2.3 Product Preparation/Blending Records

Records for Critical Control Points and/or factors significant to food safety are maintained.

Rationale

Records are necessary to verify that Critical Control Points and/or factors significant to food safety during preparation are controlled.

Anticipated Outcomes

The manufacturer keeps records that demonstrate control of product preparation/blending through adherence to Critical Control Points and/or factors significant to food safety where applicable (e.g. allergens, food additives).

7.2.4 Process Control Records

Written records that adequately reflect the control of Critical Control Points and/or factors significant to food safety during processing are kept.

Rationale

Records are necessary to verify the safety of the process.

Anticipated Outcomes
  • The manufacturer has records that demonstrate control of Critical Control Points and/or factors significant to food safety during processing.
  • Deviations are noted on the records by the operator.

Note: Minimum information required on records may vary depending on the type of process.

7.2.5 Deviation and Corrective Action Records

Records are kept to demonstrate the control of deviations and the effectiveness of corrective actions taken.

Rationale

Records are required to verify that the manufacturer has control of deviations and that corrective action has been effective.

Anticipated Outcomes
Deviation/Hold

Deviation records include information such as:

  • description of deviation and reason for the hold;
  • product and code;
  • date when the product was manufactured, held, released or destroyed;
  • amount of product held, e.g. back to the point where the process was last in control;
  • results of evaluation/sort, e.g. amount analysed, analysis report of the number and nature of defects;
  • disposition of held product, e.g. amount sorted, destroyed or returned to the supplier, employee sales, distress or salvage, reconditioning, and retail sales;
  • signature of personnel responsible for hold and evaluation; and
  • signed authorization for disposition.
Corrective Action

Corrective action records include information such as:

  • cause of deviation identified;
  • corrective action taken to correct deficiency;
  • preventive measures taken to prevent recurrence of the deviation;
  • follow-up/assessment of effectiveness of corrective action and preventive measures;
  • date corrective action and preventive measures were taken and verified; and
  • signature of person responsible.

7.2.6 Verification Records

Records are kept to demonstrate the adequacy of verification procedures.

Rationale

Records show the results of verification and confirm the conformance and effectiveness of manufacturing controls.

Anticipated Outcomes

Records of verification include the methods utilized, the date, the individuals/organizations responsible, the results/findings and the actions taken (corrective action when a deviation is found).

7.3 Records on Equipment

7.3.1 Equipment/Instrumentation Maintenance and Calibration Records

Records are kept to demonstrate adherence to the maintenance and calibration program for equipment and instrumentation that may impact on food safety.

Rationale

Records permit verification of the effectiveness of the equipment/instrumentation maintenance and calibration program.

Anticipated Outcomes
  • In Maintenance Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the maintenance activity, the date of maintenance, the person responsible and the reason for the activity.
  • In Calibration Records for equipment and/or instrumentation that may impact on food safety, the manufacturer typically includes an identification of the equipment and/or instrumentation, the date of calibration, the person responsible, the calibration results and corrective actions.

7.4 Records on Premises

7.4.1 Water and Steam Quality Records

Written records that adequately reflect control of water and steam quality and treatment are kept.

Anticipated Outcomes

The manufacturer keeps records to demonstrate the adequacy of the microbiological and chemical safety of the water and steam supply as outlined below.

Water Potability RecordsWater Treatment RecordsBoiler Feed water
Treatment Records
water source method of treatment method of treatment
sample site sample site analytical results
analytical results analytical results analyst
analyst analyst date
date date date

7.5 Records on Sanitation and Pest Control

7.5.1 Sanitation Records

Records are kept to demonstrate the effectiveness of the sanitation program.

Anticipated Outcomes

The records of sanitation activities include the date, the person responsible, the findings, the corrective action taken, and the microbiological test results where appropriate.

7.5.2 Pest Control Records

Records are kept to demonstrate the effectiveness of the pest control program.

Anticipated Outcomes

Minimum pest control records include:

  1. the results of the inspection programs and the corrective action taken (e.g. the findings in traps, the location of insect infestations);
  2. a record of pest control activities (e.g. the pesticide used, the method and location of application, the dates of fumigation); and
  3. the date and the person responsible.

7.6 Records on Complaint Handling and Recalls

7.6.1 Complaint Records

Records of product complaints, investigation findings and action taken are kept.

Rationale

Records provide verification that the appropriate action was taken within a reasonable time frame.

Anticipated Outcomes

The establishment maintains detailed records of consumer complaints received and of the subsequent investigation, including corrective action taken. Complaint records include the information listed below:

Consumer Information

The manufacturer's records contain, at a minimum:

  1. the name, address and telephone number of the complainant, and the date the complaint was received;
  2. details of the complaint and/or illness;
  3. the product's name, code and size; and
  4. the retail outlet where the product was purchased.
Investigation

The manufacturer's records contain, at a minimum:

  1. the name of person responsible for the investigation;
  2. the action taken (concerning the product and/or the process) as a result of the investigation;
  3. the corrective action taken to prevent a recurrence; and
  4. a follow-up/assessment of the effectiveness of the corrective action.

7.6.2 Distribution Records

Product distribution records are kept to enable the manufacturer to recall any lot of food in a timely fashion.

Anticipated Outcomes

Distribution records contain sufficient information to permit traceability to a particular code or lot number. The following minimum information is required for distribution records:

  1. the product identification and size;
  2. the lot number or code;
  3. the quantity; and
  4. name and type of the account, (e.g. manufacturer, distributor, retailer), addresses and phone numbers of recipients.

Chapter 8: Complaint Handling and Recalls

8.1 Complaint Handling

8.1.1 Product Complaints

The establishment has an effective system for handling and investigating complaints.

Rationale

Product complaints are an important indicator of possible deficiencies in manufacturing controls and/or deficiencies in the distribution handling system. When the complaint handling system itself is deficient, it could result in failure to identify and eliminate risks.

Anticipated Outcomes
  • The manufacturer has a system to handle and investigate product complaints which identifies the person or persons responsible for receiving, evaluating, categorizing and/or investigating complaints.
  • Complaints are accurately categorized according to safety, composition and other regulatory concerns.
  • Potentially serious complaints are forwarded immediately to appropriate personnel for action.
  • Safety and contamination complaints are investigated by appropriately trained technical personnel.
  • Examination of the complainant's specimen, the retail product or other product of the same code is conducted on complaints related to food safety.
  • Complaints pertaining to composition, fraud and other regulatory concerns are investigated in an effective manner.
  • The depth of the investigation is appropriate to the risk and similar complaint trends.
  • Appropriate corrective action is taken for deviations identified during the investigation.

See Section 7.6.1 for expected Complaint Records.

8.2 Recalls

8.2.1 Recall Procedure

The chocolate manufacturer establishes a written procedure to permit the complete, rapid recall of any lots of chocolate from the market.

Anticipated Outcomes
  • A written procedure is in place to enable the recall of any lot of product and provide detailed information to assist in the investigation of any identified produce contamination.
    Note: In some instances, the establishment may be required to recall a product because of the use of a raw ingredient or packaging material which has been determined to be unsafe. By linking raw ingredient lot codes to the finished product code, the establishment will be able to identify which of the finished products need to be recalled.
  • The written procedure identifies the person or persons responsible (e.g. recall coordinators) and the roles and responsibilities of those who coordinate and implement a recall.
  • The procedure specifies methods to identify, locate and control recalled product, and includes a requirement to investigate other products that may be affected by the hazard and should be included in the recall.
  • The procedure requires that the recall be monitored to assess its effectiveness (e.g. an "effectiveness check" is conducted to the appropriate level of distribution specified in the recall notice).
  • The Canadian Food Inspection Agency is immediately notified in the region where the manufacturer is located. This notification includes the following:
    1. the amount of product produced, the amount in inventory and the amount distributed;
    2. the name, size, code or lot numbers of the food recalled;
    3. the area in which the product was distributed (e.g. local, national, international); and,
    4. the reason for the recall.

Note: For additional information on developing a recall plan, please refer to the Food Recalls: Make a Plan and Action It! Manufacturers' Guide on the CFIA website.

See Section 7.6.2 for expected Distribution Records.

8.2.2 Recall Capability

Recall procedures are tested periodically to verify the manufacturer's capability to rapidly identify and remove product from the market.

Anticipated Outcomes
  • The manufacturer demonstrates the capability to provide accurate information on a timely basis, to verify that all affected product can be rapidly identified and removed from the marketplace. For example:
    • the manufacturer conducts periodic testing (internal simulations) to verify the capability of the procedure to rapidly identify and control a code lot of potentially affected product, and to reconcile the amount of product produced with the amount in inventory and the amount in distribution; and
    • the manufacturer identifies and corrects any deficiencies in the recall procedure.

Glossary

For the purpose of this guidance document, the following expressions have the stated definitions:

Allergens
any substance capable of producing an abnormal immune response in sensitive individuals. Priority food allergens of concern in Canada include: peanuts, tree nuts, milk, soy, wheat, sulphites, sesame seeds, egg and seafood (fish, crustaceans and shellfish).
Capability
a standardized evaluation of the inherent capability of equipment to consistently perform a specified function under actual operating conditions after significant causes of variation have been eliminated.
Chocolate
a product derived from one or more cocoa products (cocoa liquor, cocoa butter and/or cocoa powder), and may contain sweetening agents, milk ingredients, spices and other permitted ingredients. This standard also applies to bittersweet chocolate, semi-sweet chocolate and dark chocolate as per section B.04.006 of the Food and Drug Regulations.
Chocolate product
product derived from one or more cocoa products and includes chocolate, bittersweet chocolate, semi-sweet chocolate, dark chocolate, sweet chocolate, milk chocolate and white chocolate. Standards for chocolate products exist in sections B.04.006 to B.04.009 of the Food and Drug Regulations.
Contamination
the transfer of harmful substances or disease-causing microorganisms to chocolate by hands, food-contact surfaces and utensils that touch contaminated food.
Control
means that an operation performs consistently within pre-determined limits based on process capability, meets process requirements, provides a mechanism to maintain the stability of the process and consistently results in a safe product.
Corrective action
the actions to be taken when the results of any monitoring indicates a loss of control. In addition, this term refers to any action taken to bring the process into control and deal with any affected product when critical limits or other criteria are not met. The action should be prompt and appropriate to the seriousness of the deficiency.
Critical Control Point (CCP)
a point, step or procedure at which control can be applied and a food safety hazard can be prevented, eliminated, or reduced to acceptable levels.
Critical limit
a value which separates acceptability from unacceptability.
Cross-contamination
contamination of foods or packaging material by direct or indirect contact with material from an earlier stage of the process. A regulated process flow and good employee practices will minimize the risk of cross-contamination occurrences.
Deterioration
for the purposes of this document, deterioration can be used interchangeably with spoilage; however, deterioration can also apply to non-food products such as packaging materials. For non-food items, deterioration is a physical or chemical change in the material that may adversely affect the safety of the food.
Deviation
failure to meet the critical limits for a Critical Control Point or failure to meet the limits of acceptability for factors significant to food safety.
Deviation procedure
a pre-determined and documented set of corrective actions (immediate and preventive) which are implemented when a deviation occurs.
Documents
for the purposes of this document, documents refer to written formulae, procedures or specifications used by or required of a manufacturer.
Factors significant to food safety
means any property, characteristic, condition, aspect, or other parameter, variation of which may affect the safety of the product or the process.
Food contact surface
any equipment or utensil which normally comes in contact with the food product or surfaces normally in contact with the product.
Hazard
An agent, condition or circumstance that has the potential to cause illness or injury in the absence of control. Hazards can be biological, chemical or physical.

Biological include:

  • pathogenic bacteria that cause illness by infection (e.g. Salmonella) or intoxication (e.g. Clostridium botulinum, Staphylococcus aureus) and so include bacterial toxins (e.g. botulinum toxin, staphylococcus toxin);
  • viruses and parasites that cause illness by infection.

Chemical include:

  • substances or toxins that are naturally occurring and derived from plants, animals, algae and fungi (e.g. mycotoxins, poisonous mushroom) but not including bacterial toxins;
  • substances intentionally added to the food during growth or food processing and considered safe below certain established limits but unsafe above established limits (e.g. sodium, nitrate);
  • substances that contaminate food accidentally (e.g. cleaning chemicals);
  • food allergens (e.g. peanuts, tree nuts, milk, soy, seafood [fish, crustaceans and shellfish], wheat, sulphites, sesame seeds and egg).

Physical include:

material not normally found in food that can cause physical injury to the person consuming the food (e.g. broken glass, metal fragments, stones, wood slivers, bone pieces).

Hazard Analysis Critical Control Points (HACCP)
a systematic approach to identifying and assessing hazards and risks associated with a food operation and defining the means of their control.
Inspection areas
(definition with respect to lighting requirements), inspection areas are defined as any point where food products or containers are visually inspected or instruments are monitored.
Lot
means the amount of product of a specific container size, product style and code produced by a food establishment during a specified period of time.
Microorganisms
include yeasts, moulds, bacteria, viruses and parasites. When used as an adjective the term "microbial" is used.
Monitoring
a planned sequence of observations or measurements to assess whether a CCP (or other activity) is under control.
Mycotoxins
are substances produced by certain fungi (e.g. mould) in agricultural products that are susceptible to fungal infection. Some mycotoxins including aflatoxin, ochratoxin, zearalenone, patulin, ergot alkaloids, vomitoxin and fumonisin are known to constitute a food safety hazard.
Recall, Periodic testing (Recall)
internal activities conducted periodically to verify the capability of the manufacturer to rapidly identify and control a given lot of product. These activities do not necessarily require that the manufacturer contact customers.
Potable water
water which meets the requirements of the Guidelines for Canadian Drinking Water Quality published by Health Canada and any applicable provincial and municipal requirements.
Pre-packaged product
as per the Food and Drugs Act, any food that is contained in a package in the manner in which it is ordinarily sold to or used or purchased by a person.
Prerequisite program
Universal steps or procedures (e.g. Good Manufacturing Practices [GMP]) that control the operational conditions within a food establishment and promote environmental conditions that are favourable for the production of safe food.
Recall (noun)
denotes the process of recalling the affected product and encompasses all tiers of the affected product distribution system.
Recall (verb)
means for an establishment to remove from further sale or use, or to correct, a marketed product that contravenes legislation administered and/or enforced by CFIA.
Records
observations and measurements recorded by a manufacturer to determine adherence to critical limits, limits of acceptability or other specified requirements (for a Critical Control Point or for factors significant to food safety).
Refrigeration
means exposure to a temperature of 4°C or less, but does not mean frozen.
Risk
an estimate of the likelihood of occurrence of a hazard.
Sanitizing
the application of heat or chemical treatments to destroy or substantially reduce the number of microorganisms present that have the potential to cause adverse health effects.
Spoilage
a process whereby food is rendered unacceptable for consumption through microbiological or chemical reaction.
Validation
the obtaining of evidence showing that control measures are capable of being consistently effective. Validation is performed when new control measures or a new food safety control system is designed, or when changes indicate the need for revalidation, in order to confirm that the control measures or food safety control systems, when implemented as intended, are capable of controlling the hazard to the appropriate level and that this level of control can be achieved consistently.
Verification
examination of the accuracy, correctness or effectiveness of validated processes or process controls through testing, investigation or comparison against a standard.

References

  • Lund, B.M., Baird-Parker, T.C., Gould, G.W. 2000. Microbiological Safety and Quality of Food. Volumes 1- 2. Aspen Publishers, Inc. Gaithersburg, Maryland, p. 763.
  • International Commission on Microbiological Specifications of Foods (ICMSF). 1986. Microorganisms In Foods 2. Sampling for microbiological analysis: Principles and specific applications. 2nd ed. Blackwell Scientific Publications, Toronto.
  • National Confectioners Association (NCA). 2011. Industry Review.

Additional Resources:

Acts and Regulations

Canadian Food Inspection Agency

Health Canada

International

Other Resources

  • D'Aoust, J.Y., 1977. Salmonella and the chocolate industry. A review. J. Food Prot. 40, 718-727.
  • Mogelonsky M, 2007. Confronting Confectionery. Prepared Foods 176: 11-20.

Appendix A: Hazard Analysis And Critical Control Point (HACCP) Summary

This guidance document and the HACCP Generic Model for moulded chocolate were developed by the Canadian Food Inspection Agency (CFIA) in an effort to reduce the health risk(s) posed by the consumption of higher risk foods.

Hazard Analysis Critical Control Point (HACCP) is recognized as the most respected food processing concept in the world for enhancing the production of safe food. The HACCP approach involves the review of each step of the food manufacturing process, from start to finish, in order to identify every possible hazard or source of contamination. Hazards can be biological (e.g. pathogenic microorganisms), chemical (e.g. pesticides, allergens) or physical (e.g. extraneous material). For each identified hazard or source of contamination a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level.

A HACCP system is built on an establishment's existing food safety control program. The standard operating procedures developed and written by the establishment can be Good Manufacturing Practices (GMPs) or an adopted food safety code. In many HACCP guideline documents, these GMPs are referred to as prerequisite programs that represent the foundation of the HACCP Plan. The GMPs must be equivalent to the Recommended International Code of Practice – General Principles of Food Hygiene adopted by the Codex Alimentarius Commission (Codex) to ensure that adequate control exists over the environment in which the food processing is taking place.

It is generally recognized that in adopting the HACCP approach, a food processing establishment needs to carry out the following five preliminary tasks:

  1. Assemble a HACCP team with the expertise and knowledge to develop the HACCP Plan.
  2. Thoroughly describe the product and its intended use (e.g. common name, important product characteristic, shelf life, labelling instructions, etc.).
  3. List all product ingredients and incoming materials that come in contact with the product or are used in preparing the product.
  4. Develop an accurate and detailed Process Flow Diagram (from raw material receiving to finished product shipping) and Plant Schematic/Blueprint showing product and traffic flow.
  5. Verify the Process Flow Diagram and Plant Schematic on-site.

After completing the preliminary tasks, the HACCP team develops the HACCP Plan by applying the seven principles of HACCP to each food category processed.

Principle 1

Conduct a hazard analysis (HA) from the receiving of raw materials to the use of the finished product by the consumer.

Note: Information on food hazards (e.g. biological, chemical and physical hazards) can be obtained from scientific publications and industry associations.

Principle 2

Apply the HACCP decision tree to determine Critical Control Points (CCPs).

Principle 3

Establish critical limits, i.e. criteria that define acceptability and unacceptability of food products.

Principle 4

Establish monitoring procedures to ensure that the critical limits are being met.

Principle 5

Establish deviation procedures when monitoring at a CCP indicates a deviation from an established critical limit.

Principle 6

Establish procedures for verification to confirm the company's conformance to and the effectiveness of the HACCP Plan.

Principle 7

Establish documentation and records, including the HACCP Plan details, processing records, as well as HACCP-related monitoring and verification records.

The HACCP Generic Model, developed following the CFIA's Food Safety Enhancement Program (FSEP) approach, includes all of the seven principles outlined above. It provides information to be used by the establishment in developing a plant-specific HACCP Plan. The Generic Model includes an example of a process flow diagram and identifies possible food safety hazards associated with each step in the process. Using the Codex Alimentarius decision tree, the Generic Model determines the points in the process where Good Manufacturing Practices (GMPs) in place at the facility do not control the potential hazard (Critical Control Points). For each of the Critical Control Points in the process, the Generic Model provides examples of:

  • procedures to be implemented in order to ensure that the hazard is controlled (i.e. monitoring procedures);
  • procedures to be implemented when monitoring determines that the hazard is no longer controlled and a possible food safety hazard could exist (i.e. deviation procedures); and,
  • procedures to be implemented to ensure that both the monitoring procedures and the deviation procedures are being followed and are effective in controlling the identified hazards (i.e. verification procedures).

It is hoped the HACCP Generic Model will provide guidance and information to manufacturers in developing their own HACCP Plan. Each manufacturer must create its own process flow diagram according to its specific practices and procedures. Moreover, hazards and how they are controlled as described in the Generic Model will need to be changed where necessary to reflect a manufacturer's unique flow diagram and/or product characteristics.

Additional information on developing a HACCP Plan can be found in the FSEP Manual on the CFIA website.

This guidance document includes a proposed GMPs guide that could serve as a prerequisite program. As mentioned above, by implementing GMPs the manufacturer could control many of the hazards identified for each step in the process. This document also includes information on process controls. Both the Generic Model and this guidance document are intended to be tools for the food industry's voluntary use in creating a food safety control system.

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